K111472

Substantially Equivalent

HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON

Applicant: Tgm Medical
Product code: LPH
Advisory panel: Orthopedic
Date received: 2011-05-27
Decision date: 2011-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado, CA, US

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.