M2A MAGNUM SYSTEM
Report
- Report Number
- 0001825034-2016-04025
- Event Type
- Injury
- Date Received
- October 10, 2016
- Date of Event
- January 21, 2016
- Report Date
- December 15, 2020
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWA
- PMA / PMN Number
- PK042037
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE M2A-MAGNUM MOD HD SZ 50MM AND ONE M2A-MAGNUM PF CUP 56ODX50ID WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE HEAD TAPER HAS A BLACK LINE AROUND THE INSIDE AND DAMAGE TO THE FACE OF THE DEVICE. THE OUTSIDE RADIUS HAS SOME SCUFFING. THE CUP HAS SCUFFING TO THE INSIDE RADIUS AND THERE IS DEBRIS ON THE OUTSIDE RADIUS. NEW ADDITIONAL INFORMATION WOULD NOT CHANGE THE PREVIOUS INVESTIGATION. 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.
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - NI. MANUFACTURE DATE ¿ NI. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.
(B)(4). CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. CONCOMITANT PRODUCTS: PART 157454, LOT 920780, NAME: M2A- MAGNUM MOD HEAD. PART 139266, LOT 772870, NAME: M2A- MAGNUM TPR INSERT. PART XL80320, LOT 434250, NAME: BI-METRIC STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-04025, 0001825034-2017-01646.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS UNABLE TO 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.
PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.
IT WAS REPORTED A PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE NOTE REPORTED REVISION DUE TO PAIN AND POSSIBLE ADVERSE LOCAL TISSUE REACTION TO METAL DEBRIS. DURING THE PROCEDURE, HETEROTOPIC BONE, PSEUDOCAPSULE, BROWNISH DISCOLORATION ON THE SYNOVIAL TISSUE, AND NO EVIDENCE OF METALLOSIS WAS NOTED. THE MODULAR HEAD AND ACETABULAR CUP WERE REVISED; A POLY LINER WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666246 | M2A MAGNUM SYSTEM | PROSTHESIS, HIP | KWA | BIOMET ORTHOPEDICS | N/A | 980940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |