BIOMET HIP SYSTEM
Report
- Report Number
- 0001825034-2026-00682
- Event Type
- Death
- Date Received
- March 23, 2026
- Date of Event
- February 14, 2023
- Report Date
- May 11, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- K990830
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). D10: CAT# 650-0332, LOT# UNK, TAPERLOC LAT COCR 10MM T1. G2: FOREIGN ¿ EVENT OCCURRED IN THE NETHERLANDS. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B5; B7; D4 LOT; D10; G2; G3; H2. THE FOLLOWING SECTIONS WERE CORRECTED: E1 CONTACT; E2; E3. D10: CAT# 650-0332 LOT# 7260478 TAPERLOC LAT COCR 10MM T1. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST RIGHT HIP IMPLANTATION, THE PATIENT PASSED AWAY FOLLOWING A CARDIAC ARREST AND RESUSCITATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST RIGHT HIP IMPLANTATION, THE PATIENT PASSED AWAY FOLLOWING A CARDIAC ARREST AND RESUSCITATION. THE PATIENT CAUSE OF DEATH WAS MULTI-ORGAN FAILURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331137 | BIOMET HIP SYSTEM | PROSTHESIS, HIP | LPH | ZIMMER BIOMET, INC. | J7314854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |