M2A-MAGNUM MOD HD SZ 46MM 46MM
Report
- Report Number
- 0001825034-2020-00839
- Event Type
- Injury
- Date Received
- February 24, 2020
- Date of Event
- January 19, 2021
- Report Date
- November 4, 2021
- Product Code
- LPH
- PMA / PMN Number
- K101336
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
B3: (B)(6) 2019. REPORTED EVENT WAS CONFIRMED WITH REPORTED BLOOD SERUM LEVELS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS 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.
ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES ELEVATED IONS (CHROMIUM LEVELS RECEIVED), ALTR, PAIN, AS REPORTED. NO COMPLICATIONS NOTED. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF 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.
IT WAS REPORTED BY PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED APPROXIMATELY 11 YEARS LATER DUE TO THE PATIENT HAD HIGH METAL ION LEVELS ALLEGEDLY FROM THE REMAINING METAL ON METAL IMPLANT IN HER LEFT HIP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED BY PATIENT¿S LEGAL COUNSEL INITIAL LEFT TOTAL HIP ARTHROPLASTY, SUBSEQUENTLY REVISED ON TWELVE (12) YEARS POST IMPLANTATION DUE TO ELEVATED METAL IONS, PAIN, AND ALTR. DURING THE REVISION MILKY FLUID CONSISTENT WITH ALTR WAS NOTED, STEM WELL FIXED AND REMAINED INTACT, AND ACETABULUM IN GOOD ALIGNMENT, WELL FIXED AND REMAINED INTACT. THE TAPER ADAPTER AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: US157852 M2A-MAGNUM PF CUP 52ODX46ID 789780, 139256 M2A-MAGNUM 42-50 TPR INSRT 949830, 192011 ECHO POR FMRL NC 11X135MM 791360. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. 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 - 2020 - 00838 CUP.
PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. APPROXIMATELY TEN YEARS POST IMPLANTATION, IT WAS DISCOVERED THAT THE PATIENT HAD HIGH METAL ION LEVELS ALLEGEDLY FROM THE REMAINING METAL ON METAL IMPLANTS IN HER LEFT HIP. NO MEDICAL INTERVENTION HAS BEEN REPORTED TO DATE. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 209634 | M2A-MAGNUM MOD HD SZ 46MM 46MM | PROSTHESIS, HIP | LPH | N/A | 729070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |