ARCOM 28MM RNGLOC LNR HWALL 23
Report
- Report Number
- 0001825034-2024-00735
- Event Type
- Injury
- Date Received
- March 20, 2024
- Report Date
- July 16, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- UDI-DI
- 05019279348510
- PMA / PMN Number
- K926107
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GG
- Reporter Occupation
- 003
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
(B)(4). D10: 50-152309, LOT#: 02063410. G2: FOREIGN: GEORGIA . MULTIPLE MDRS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-00793 AND 0001825034-2024-00794. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED H3 OTHER TEXT: DEVICE REMAINS IMPLANTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED} UPDATED: G3; H2; H3; H4; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT THA WAS PERFORMED ON AN UNKNOWN DATE. SUBSEQUENTLY THE PATIENT BEGAN EXPERIENCING PAIN AND DIFFICULTY AMBULATING. A REVISION OCCURRED AND POLY WEAR WAS NOTED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SEVERE POLYETHYLENE LINER WEAR OF THE RIGHT HIP ARTHROPLASTY AS NOTED WITH EXTENSIVE ACETABULAR AND PROXIMAL FEMORAL OSTEOLYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4 B5 D6B E1: ADDRESS AND PHONE NUMBER G3 G6 H2 H10.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D6A: IMPLANTATION DATE IS SOMETIME IN 2007.
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
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.
NO FURTHER INFORMATION 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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 527740 | ARCOM 28MM RNGLOC LNR HWALL 23 | PROSTHETIC, HIP | LPH | ZIMMER BIOMET, INC. | N/A | 688297 | 05019279348510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other| H |