PFC SIGMARP STB TB IN 3 10.0
Report
- Report Number
- 1818910-2021-28948
- Event Type
- Injury
- Date Received
- December 29, 2021
- Date of Event
- October 20, 2021
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- NJL
- UDI-DI
- 10603295241249
- PMA / PMN Number
- P830055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). 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 : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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 EVALUATION (MRE) WAS NOT PERFORMED.
PRODUCT COMPLAINT # (B)(4).
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.
CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS POLYETHYLENE WEAR. DATE OF IMPLANTATION: (B)(6) 2002. DATE OF REVISION: (B)(6) 2021. (RIGHT KNEE) TREATMENT: REVISION OF TIBIAL INSERT AND PATELLA COMPONENTS. PRODUCT DETAILS: CATALOG: 129434130, LOT: U4FER1007, DESCRIPTION: MBT POROCOAT KEEL SZ 3. CATALOG: 960053, LOT: 286624, DESCRIPTION: SIGMA FEM POST/STAB CEMENTED RT SZ 3. CATALOG: 960112, LOT: 1022501, DESCRIPTION: SIGMA PATELLA ROUND DOME 3 PEGGED 38.0MM. CATALOG: 962131, LOT: 77005A, DESCRIPTION: SIGMA TIBIAL INSERT RP POST/STAB SZ 3 10MM. CATALOG: 545033000, LOT: V4CC94000, DESCRIPTION: ENDURANCE BONE CEMENT 40G. CATALOG: 545033000, LOT: V4CC94000, DESCRIPTION: ENDURANCE BONE CEMENT 40G.
REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN AND INSTABILITY. UPON ENTERING THE JOINT, SYNOVITIS WAS ENCOUNTERED AND REMOVED. THE TIBIAL INSERT AND PATELLA COMPONENTS WERE SIGNIFICANTLY WORN AND PIECES WERE FRACTURES OFF OF EACH. A COMPREHENSIVE LAVAGE WAS PERFORMED ¿ NO INDICATION OF ANY PIECES OF POLY BEING LEFT IN THE PATIENT. THE INSERT AND PATELLA COMPONENTS WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2010437 | PFC SIGMARP STB TB IN 3 10.0 | SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT | NJL | DEPUY ORTHOPAEDICS INC US | 96-2131 | 77005A | 10603295241249 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female | Required Intervention | DEPUY 3 SYRINGEABLE CEMENT 40G| DEPUY 3 SYRINGEABLE CEMENT 40G| MBT POR KEEL TIB TRAY SZ3| PFC*SIGMA C/S NPOR FEM RT SZ 3| PFC*SIGMA/RD/DOME PAT 3PEG,38 |