METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS— 510(k) K113271

Substantially Equivalent

Biomet Manufacturing, Inc.

FDA 510(k) clearance K113271 for METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS, Substantially Equivalent on 2012-05-18. Applicant: Biomet Manufacturing, Inc..

Clearance details

Applicant: Biomet Manufacturing, Inc.
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 2011-11-04
Decision date: 2012-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.