UNKNOWN HEAD
Report
- Report Number
- 0001825034-2024-00794
- Event Type
- Injury
- Date Received
- March 20, 2024
- Report Date
- July 16, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- NI
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GG
- Reporter Occupation
- 003
Narratives
(B)(4). D10: 11-105903 ITEM NAME ARCOM 28MM RNGLOC LNR HWALL 23 LOT # 688297. 50-152309 ITEM NAME BIMETRIC STEM LOT # 02063410. UNKNOWN HEAD. G2: FOREIGN: GEORGIA. MULTIPLE MDRS WERE FILED FOR THIS EVENT, PLEASE SEE THE ASSOCIATED REPORTS 0001825034 - 2024 - 00735. 0001825034 - 2024 - 00793. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THERE ARE NO ALLEGATIONS AGAINST THIS DEVICE. THE INITIAL REPORTS SHOULD BE VOIDED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: B4. B5. D6A: IMPLANTATION DATE IS SOMETIME IN 2007. G3. G6. H2. H10.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: A2: AGE.
IT WAS REPORTED THAT THE PATIENT NEEDS TO UNDERGO A REVISION 20 YEARS POST IMPLANTATION DUE TO PAIN. THE PATIENT IS UNABLE TO WALK WITHOUT A WALKING STICK AND PUS MAY HAVE ACCUMULATED IN THE PATIENT'S HIP. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 20 YEARS POST IMPLANTATION DUE TO PAIN. THE PATIENT WAS UNABLE TO WALK WITHOUT A WALKING STICK AND PUS MAY HAVE ACCUMULATED IN THE PATIENT'S HIP DUE TO THE IMPLANTS. ONLY THE LINER HAS BEEN EXCHANGED AT THIS TIME. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 17 YEARS POST IMPLANTATION DUE TO IMPLANT WEAR WITH PAIN AND DIFFICULTY AMBULATING. ONLY THE LINER HAS BEEN EXPLANTED AT THIS TIME. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2129510 | UNKNOWN HEAD | PROSTHETIC, HIP | LPH | ZIMMER BIOMET, INC. | N/A | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other| H | PLEASE SEE H10 |