PFC*SIGMA DI AUG16MMCO,SZ4RGHT
Report
- Report Number
- 1818910-2021-05934
- Event Type
- Malfunction
- Date Received
- March 24, 2021
- Date of Event
- March 4, 2021
- Report Date
- March 4, 2021
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JWH
- UDI-DI
- 10603295234456
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: THE OVERALL ALL COMPLAINT WAS NOT CONFIRMED DUE TO NONE OF THE PACKING COMPONENTS WERE RETURNED WITH THE DEVICE. THERE WAS NO INDICATION OF A DESIGN OR MANUFACTURING ISSUE WITH THE RETURNED DEVICE. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. DEVICE HISTORY LOT: A DHR REVIEW WAS CONDUCTED BY THE MANUFACTURING SITE. THE DHR REVIEW REVEALED, NO RELATED NONCONFORMANCE ASSOCIATED WITH THE PROVIDED PRODUCT CODE AND LOT COMBINATION (P/N 960892, LOT C12235).
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: D9. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: H3.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE OR ASSOCIATED PACKAGING COMPONENTS WERE RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A DHR REVIEW WAS CONDUCTED BY THE MANUFACTURING SITE. THE DHR REVIEW REVEALED, ONE UNRELATED NONCONFORMANCE (NR-0036132) ASSOCIATED WITH THE PROVIDED PRODUCT CODE AND LOT COMBINATION.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
THE INCIDENT OCCURRED DURING THE SURGERY WITH A 5 MINUTES DELAY TIME TO TAKE ANOTHER IMPLANT AND TO MAKE THE FINAL ASSEMBLY FOR THE SURGERY.
(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PROCEDURE: KNEE RECOVERY. THE 2 PACKAGINGS OF THE IMPLANT HAVE HOLES (MAYBE MADE BY THE DEVICE ITSELF). HOWEVER, THE BOX OF THE IMPLANT WAS INTACT (HERMETIC AND DID NOT HAVE HOLES). DATE OF THE EVENT: (B)(6) 2021. THE INCIDENT OCCURRED DURING THE SURGERY. DELAY : 5 MIN, TIME TO TAKE ANOTHER IMPLANT AND TO MAKE THE FINAL ASSEMBLY FOR THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 460444 | PFC*SIGMA DI AUG16MMCO,SZ4RGHT | SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY | JWH | DEPUY ORTHOPAEDICS INC US | 96-0892 | C12235 | 10603295234456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |