M2A-MAGNUM 42-50MM TPR INSRT-6
Report
- Report Number
- 0001825034-2018-08771
- Event Type
- Injury
- Date Received
- September 19, 2018
- Date of Event
- March 20, 2017
- Report Date
- December 17, 2020
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LPH
- PMA / PMN Number
- PK030055
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D10; G4; H2; H3; H6 COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED A M2A-MAGNUM MOD HD SZ 42MM, PART # 157442 FROM LOT 200260, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE HEAD TO BE ASSEMBLED WITH THE TAPER INSERT UPON RECEIPT. SCUFFING AND SCRATCHING WAS FOUND ON THE OUTER RADIUS CONSISTENT WITH METAL ON METAL CONSTRUCTION. NO MAJOR DAMAGE WAS OBSERVED. A M2A-MAGNUM 42-50MM TPR INSRT-6, PART # 139252 FROM LOT 407140, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE INSERT REMAINS ASSEMBLED WITH THE HEAD UPON RECEIPT. LIGHT SCRATCHING WAS OBSERVED AROUND THE RIM OF THE TAPER AND ETCHING. AN UNIDENTIFIABLE WHITE DEBRIS WAS FOUND INSIDE THE TAPER OF THE INSERT. A M2A-MAGNUM PF CUP 48ODX42ID, PART # US157848 FROM LOT 926780, WAS ALSO RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE INNER RADIUS OF THE CUP IS SCUFFED AND WORN CONSISTENT WITH METAL ON METAL CONSTRUCTION. ONE OF THE FINS ON THE OUTER RADIUS IS CHIPPED. BONE CEMENT AND FOREIGN DEBRIS ARE STILL AFFIXED TO THE POROUS COATING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT 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.
(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 157442 M2A-MAGNUM MOD HD SZ 42MM LOT# 200260, ITEM# 11-104112 MLRY-HD POR FMRL 12X165MM LOT# 787550, ITEM# US157848 M2A-MAGNUM PF CUP 48ODX42ID LOT# 926780. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 08770, 0001825034 - 2018 - 08769, 0001825034 - 2018 - 08768.
IT WAS REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 5 YEARS AGO. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS POST OP DUE TO PAIN. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 732090 | M2A-MAGNUM 42-50MM TPR INSRT-6 | PROSTHESIS HIP | LPH | ZIMMER BIOMET, INC. | N/A | 407140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | SEE H10 NARRATIVE |