SIGMA PS CEM FEM SZ3 R
Report
- Report Number
- 1818910-2024-12546
- Event Type
- Injury
- Date Received
- June 7, 2024
- Date of Event
- January 1, 2022
- Report Date
- June 7, 2024
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JWH
- PMA / PMN Number
- P830055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : IT WAS REPORTED THAT THE PATIENT FELL IN 2022 AND SUFFERED A TIBIAL FRACTURE. THIS APPEARS TO HAVE CAUSE THE TIBIAL PLATEAU TO COLLAPSE OVER TIME. PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2024 AT HOSPITAL, THE TIBIA CAME OFF RELATIVELY EASILY, WITH NO CEMENT ATTACHED TO THE BOTTOM OF THE TIBIA. THE CEMENT USED IS BELIEVED TO BE A COMPETITOR AT THE TIME. THIS IS THE SECOND SIGMA TIBIAL BASE THAT WE WAS REMOVED IN ABOUT 4 WEEKS. BOTH HAD NO CEMENT ON THE TIBIA, ONLY ON BONY INTERFACE. THE FEMUR WAS WELL FIXED, HOWEVER THE FROZEN TISSUE CAME BACK AS INFECTED. SO ALL IMPLANTS WERE REMOVED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE X-RAY INVESTIGATION REVEALED NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE SIGMA PS CEM FEM SZ3 R WOULD NOT CONTRIBUTE TO THE REPORTED ADVERSE EVENT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 196050300 / 8982985 LOT NUMBER, AND NO NON-CONFORMANCES /MANUFACTURING IRREGULARITIES WERE IDENTIFIED.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT THE PATIENT FELL IN 2022 AND SUFFERED A TIBIAL FRACTURE. THIS APPEARS TO HAVE CAUSED THE TIBIAL PLATEAU TO COLLAPSE OVER TIME. PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2024 AT HOSPITAL, THE TIBIA CAME OFF RELATIVELY EASILY, WITH NO CEMENT ATTACHED TO THE BOTTOM OF THE TIBIA. THE CEMENT USED IS BELIEVED TO BE A COMPETITOR AT THE TIME. THE FEMUR WAS WELL FIXED, HOWEVER THE FROZEN TISSUE CAME BACK AS INFECTED. SO ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2019, DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1276421 | SIGMA PS CEM FEM SZ3 R | SIGMA KNEE PRIMARY : KNEE FEMORAL | JWH | DEPUY ORTHOPAEDICS INC US | 8982985 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Female | Required Intervention | BIOMET CEMENT| HP STRL QUICK DRL PINS| HP STRL THREADED PINS HEADED| MBT CEM KEEL TIB TRAY SZ2.5| PFC*SIGMA/RD/DOME PAT 3PEG,32| SIG RP AOX STB INS SZ3 10 |