LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 56 MM O.D. SHELL
Report
- Report Number
- 0002648920-2022-00098
- Event Type
- Injury
- Date Received
- April 18, 2022
- Report Date
- July 8, 2022
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- LPH
- UDI-DI
- 00889024124769
- PMA / PMN Number
- K990135
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). UNKNOWN DAY IN (B)(6) 2021 . THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 -2022 -01124, 0002648920 -2022 -00098, 0001822565 -2022 -01125, 0001822565 -2022 -01126.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D10: REF (B)(4). LOT 3011773. CERAMIC FEMORAL HEAD.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RELATIVELY NORMAL APPEARANCE OF THE BILATERAL TOTAL HIP ARTHROPLASTIES. IT IS NOTED THAT THERE IS SLIGHT LATERAL ECCENTRIC POSITIONING OF THE FEMORAL TIPS IN BOTH OF THE ARTHROPLASTIES, NONSPECIFIC AND POTENTIALLY RELATED TO INITIAL SURGICAL TECHNIQUE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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: H2; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.
IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT STATES TO HAVE HAD PAIN IN THE GROIN AND BOTH LEGS SINCE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT STATES TO HAVE HAD PAIN IN THE GROIN AND BOTH LEGS SINCE THE PROCEDURE. THE DOCTOR TOLD THE PATIENT THAT THE IMPLANTS WERE INSTALLED CROOKED. NO REVISION HAS BEEN REPORTED TO DATE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2627445 | LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 56 MM O.D. SHELL | PROSTHESIS, HIP | LPH | ZIMMER MANUFACTURING B.V. | N/A | 64629601 | 00889024124769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |