M2A MAGNUM TAPER ADAPTER 52-60MM MINUS 3MM
Report
- Report Number
- 0001825034-2018-09396
- Event Type
- Injury
- Date Received
- October 8, 2018
- Date of Event
- November 9, 2016
- Report Date
- July 30, 2019
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWA
- PMA / PMN Number
- PK042037
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09395 - 1.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
REPORTED EVENT WAS CONFIRMED WITH OPERATIVE NOTES PROVIDED. REVISION OP NOTES DEMONSTRATED THAT THE PATIENT WAS REVISED DUE TO PSEUDOTUMOR AND PAIN. DURING THE REVISION ABDUCTORS NOTED TO BE DETACHED OFF OF THE FEMUR. THE SURGEON COULD NOT REMOVE THE HEAD FROM AND STEM, AND THE WELL-FIXED STEM WAS REMOVED VIA TROCHANTERIC OSTEOTOMY. ACETABULAR SHELL WELL-FIXED AND IN GOOD POSITION. ACTIVE ARTICULATION SYSTEM PLACED AND OSTEOTOMY REPAIRED WITH 3 CERCLAGE WIRES WITHOUT FURTHER COMPLICATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ADDITIONAL INFORMATION DOES NOT AFFECT THE ROOT CAUSE. 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.
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.
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO LOCATION OF PRODUCT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09395.
IT WAS REPORTED PATIENT¿S LEFT HIP WAS REVISED APPROXIMATELY 8 YEARS POST IMPLANTATION. DURING THE REVISION SURGERY, THE FEMORAL HEAD HAD BEEN FOUND TO HAVE COLD WELDED ONTO THE STEM, WHICH REQUIRED THE SURGEON TO PERFORM AN EXTENDED TROCHANTERIC OSTEOTOMY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 783758 | M2A MAGNUM TAPER ADAPTER 52-60MM MINUS 3MM | PROSTHESIS, HIP | KWA | ZIMMER BIOMET, INC. | N/A | 792640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 11-104113 287210 MLRY-HD POR FMRL 13X170MM| 157452 996800 M2A-MAGNUM MOD HD SZ 52MM| US157858 195580 M2A-MAGNUM PF CUP 58ODX52ID |