PERSONA ALL POLY PAT PLY 26MM
Report
- Report Number
- 0002648920-2018-00517
- Event Type
- Injury
- Date Received
- June 28, 2018
- Report Date
- June 21, 2019
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- JWH
- PMA / PMN Number
- K113369
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI # - NEEDS CORRECTED TO UNKNOWN. 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.
REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS RECEIVED. REVISION OPERATIVE NOTES PROVIDED STATE THAT THE SURGEON INDICATES THAT THE PATIENT HAD SUPERFICIAL INFECTION IN HIS KNEE IN PREVIOUS POST OPERATIVE COURSE. THERE WAS SOME CONCERN THAT THE PATIENT MIGHT HAVE SUBCLINICAL INFECTION WHICH MAY BE CAUSING THE CHRONIC PAIN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE CANNOT 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). PERSONA FEMORAL CR: CATALOG#: 42-5026-064-02 LOT#: 62830391, PERSONA ALL POLY PATELLA: CATALOG#: 42-5400-000-32 LOT#: 62816540, PERSONA TIBIAL STEM: CATALOG#: 42-5320-071-02 LOT#: 63078072, PERSONA ARTICULAR SURFACE: CATALOG#: 42-5220-005-11 LOT#: 62559453. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION 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: 0001822565-2018-03482, 0002648920-2018-00517, 0002648920-2018-00518, 0001822565-2018-03483. 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. MW5072178. PRODUCT LOCATION UNKNOWN.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORT SENT TO FDA: MW5070268-3. IF ANY INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. (B)(4).
IT WAS REPORTED THAT PATIENT EXPERIENCED SUPERFICIAL INFECTION AND POSSIBLY A CHRONIC INFECTION OF THE KNEE DUE TO ELEVATED INFLAMMATORY MARKERS. IT IS UNKNOWN WHEN THE INFECTION OCCURRED OR IF ANY PREVIOUS TREATMENT WAS GIVEN.
IT WAS FURTHER REPORTED THAT THE PHYSICIAN STATED THERE WAS NO EVIDENCE OF INFECTION. HOWEVER, THE PATIENT IS REACHING OUT TO GET A SECOND OPINION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487972 | PERSONA ALL POLY PAT PLY 26MM | PROSTHESIS, KNEE | JWH | ZIMMER MANUFACTURING B.V. | N/A | 62816540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |