PFC KEEL TIB TRAY CEM SZ5
Report
- Report Number
- 1818910-2023-05278
- Event Type
- Injury
- Date Received
- March 8, 2023
- Date of Event
- February 23, 2023
- Report Date
- March 8, 2023
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JWH
- UDI-DI
- 10603295216452
- PMA / PMN Number
- K961685
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO DEPUY SYNTHES FOR EVALUATION. REVIEW OF THE PHOTOGRAPHIC EVIDENCE WAS NOT ABLE TO CONFIRM THE COMPLAINT. NO SERIES OF CHRONOLOGICAL X-RAY WAS PROVIDED AND NO SIGNS OF IMPLANT LOOSENING ON THE EXPLANTED DEVICE WERE OBSERVED. EXTRACTION MARKS CAN BE OBSERVE ON THE TIBIAL TRAY. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS (MRE) WAS NOT PERFORMED.
PRODUCT COMPLAINT # (B)4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY; THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED TO DEPUY SYNTHES FOR EVALUATION. REVIEW OF THE PHOTOGRAPHIC EVIDENCE WAS NOT ABLE TO CONFIRM THE COMPLAINT. NO SERIES OF CHRONOLOGICAL X-RAY WAS PROVIDED AND NO SIGNS OF IMPLANT LOOSENING ON THE EXPLANTED DEVICE WERE OBSERVED. EXTRACTION MARKS CAN BE OBSERVE ON THE TIBIAL TRAY. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT; THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS (MRE) WAS NOT PERFORMED.
REVISION OF A PFC TKR DONE IN 2006. MALE, LEFT SIDE. ON THE JOINT REGISTRY FORM, THE REASON FOR REVISION WAS DUE TO DEEP INFECTION, TIBIAL LOOSENING, FEMUR LOOSENING. WHEN EXPOSURE WAS DONE THE SURGEON NOTED SIGNIFICANT POLY WEAR AS SEEN IN THE PICS. ALL COMPONENTS WERE REMOVED AND ATTUNE REVISION WAS IMPLANTED. THE PATIENT NOTES WERE UNAVAILABLE SO I WAS UNABLE TO GET THE LOT NUMBERS FROM THE IMPLANT STICKERS. THE ONLY LOT NUMBER I WAS ABLE TO READ ON THE IMPLANTS WAS FOR THE ONE STATED IN THE IMPACTED PRODUCTS. 86-4183 PFC KEELED TIBIAL TRAY SZ 5. THE TIBIA WAS VERY LOOSE. AS YOU CAN SEE IN THE PIC THERE IS CEMENT ON THE IMPLANT, SO BOTH INTERFACES FAILED. THE FEMUR FAILED AT THE BONE-CEMENT INTERFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1727756 | PFC KEEL TIB TRAY CEM SZ5 | SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY | JWH | DEPUY ORTHOPAEDICS INC US | 86-4183 | 2067657 | 10603295216452 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention | PFC*SIGMA C/R NPOR FEM LT SZ5| SIGMA CRVD GVF INS 5 10MM| UNKNOWN BONE CEMENT |