M2A MODULAR HEAD COMPONENT STANDARD NECK
Report
- Report Number
- 0001825034-2019-02238
- Event Type
- Injury
- Date Received
- May 21, 2019
- Date of Event
- February 27, 2018
- Report Date
- July 21, 2020
- Manufacturer
- .
- Product Code
- KWA
- PMA / PMN Number
- K082446
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G4, H2, H3, H6. MEDICAL RECORDS RECEIVED NOTED PSEUDOTUMOR REACTION, PAIN, CORROSION AND STRESS SHIELDING. DEVICE HISTORY RECORD (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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE {UPDATE/CORRECTED}. UPDATED: B5, G4, H6.
THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER THE REPORTED EVENT COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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.
IT WAS REPORTED A PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 15 YEARS POST IMPLANTATION DUE TO PAIN, PSEUDOTUMOR, IN-VIVO CORROSION, BONE REMODELING, ROM LIMITED MOBILITY, AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT FINDINGS INCLUDED MILD TO MODERATE CORROSION AT THE HEAD-NECK JUNCTION AND MINIMAL BONE LOSS. REMAINING BONE WAS QUITE SOFT, APPEARING TO HAVE BEEN SIGNIFICANTLY STRESS SHIELDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
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, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART: 180004, BALANCE PRIMARY HIP 9 X150 RT, LOT: 562610, PART: 10-104054, M2A-T M/H RAD 2HL SHL 41/54MM, LOT: 980750, PART: 15-105002, M2A-TAPER LINER, LOT: 043570. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: LINER: 0001825034-2019-02239.
IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY DUE TO AVASCULAR NECROSIS AND WAS SUBSEQUENTLY REVISED APPROXIMATELY FIFTEEN YEARS POST-IMPLANTATION DUE TO ALLEGATIONS OF PAIN, DISCOMFORT, LACK OF MOBILITY, UNABLE TO PERFORM ACTIVITIES OF DAILY LIVING, AND ELEVATED METAL IONS IN BLOOD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421472 | M2A MODULAR HEAD COMPONENT STANDARD NECK | PROSTHESIS, HIP | KWA | . | N/A | 880950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | SEE H10. |