ATTUNE CR FB INSRT SZ 7 8MM
Report
- Report Number
- 1818910-2023-13309
- Event Type
- Malfunction
- Date Received
- June 28, 2023
- Date of Event
- June 14, 2023
- Report Date
- June 28, 2023
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- JWH
- UDI-DI
- 10603295045915
- PMA / PMN Number
- K101433
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 A MANUFACTURING RECORD EVALUATION (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE - 151620708. , LOT CODE - J6443R AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.
PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED,SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION,MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.
PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY :PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: ATTUNE CR FB CONSTRUCT WAS USED FOR RIGHT TKR IN 61 YRS OLD MALE. SZ 7 8MM TIBIAL INSERT FIXED BEARING WAS SELECTED. WHEN IMPLANT WAS IMPACTED, IT WAS SITTING IN THE TRAY HOWEVER IT WASN'T ENGAGED FULLY. 2 MORE ATTEMPTS WERE MADE TO IMPACT THE IMPLANT. NEW INSERT OF THE SAME TYPE WAS OPENED AND IMPACTED. NO ISSUES WERE REPORTED WITH THE SECOND INSERT. FEMORAL COMPONENT USED IN THE CASE - REF (B)(4).LOT 4031589 EXP 2023-12-31. TIBIAL COMPONENT USED IN THE CASE - REF (B)(4). LOT 4046881 EXP. 2033-02-28. THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED TIBIAL INSERT FOUND EVIDENCE OF DEFORMATION/WITNESS MARKS ALONG ONE OF THE POSTERIOR GROOVES THAT IS DESIGNED TO SLIDE INTO THE LOCKING FEATURE OF THE MATING TIBIAL TRAY. THE OBSERVED DAMAGE IS CONSISTENT WITH UNSUCCESSFUL INSERTION ATTEMPTS DURING THE PROCEDURE. THE MATING TIBIAL TRAY COMPONENT WAS NOT RETURNED, THEREFORE, A FUNCTIONAL TEST WAS NOT ABLE TO BE PERFORMED. HOWEVER, DUE TO THE VISUAL DAMAGE OBSERVED, THE DIFFICULTY/INABILITY TO ASSEMBLE MATING DEVICES CAN BE CONFIRMED. THE ATTUNE KNEE SYSTEM SURGICAL TECHNIQUE (DSUS/JRC/0316/1437 REV. K) ADVISES ON PAGES 79-80, ¿FOR FIXED BEARING TIBIAL COMPONENTS, ANGLE THE TIBIAL INSERT POSTERIORLY AND SLIDE THE POSTERIOR TABS INTO THE POSTERIOR UNDERCUTS OF THE TIBIAL BASE. THE FIXED BEARING TIBIAL INSERT IS IMPACTED INTO PLACE ON THE TIBIAL BASE, USING THE FIXED BEARING INSERT IMPACTOR. POSITION AN IMPACTOR AT APPROXIMATELY 60 DEGREES ON THE INSERT SO THAT THE NOTCH RESTS ON THE ANTERIOR EDGE OF THE CENTER OF THE INSERT. USE A MALLET TO STRIKE THE FIXED BEARING INSERT IMPACTOR.¿ FOLLOWING THESE STEPS WILL SUCCESSFULLY LOCKING THE INSERT INTO THE BASE AS INTENDED. THE OBSERVED DAMAGED CONDITION SUGGESTS THE POSTERIOR GROOVES ON THE UNDERSIDE OF THE TIBIAL INSERT WERE NOT PROPERLY ALIGNED WITH THE UNDERCUT LOCKING FEATURES OF THE TIBIAL BASE. THIS WOULD CONTRIBUTE TO THE DIFFICULTY/INABILITY TO MATE THE INSERT WITH THE TIBIAL COMPONENT FOLLOWING MULTIPLE INSERTION ATTEMPTS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE [151620708 / ATTUNE CR FB INSRT SZ 7 8MM / J6443R] WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USER ERROR, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE - 151620708, LOT CODE - J6443R AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED
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.
IT WAS REPORTED THAT THE ATTUNE CR FB CONSTRUCT WAS USED FOR RIGHT TKR. THE TIBIAL INSERT FIXED BEARING WAS SELECTED. WHEN IMPLANT WAS IMPACTED, IT WAS SITTING IN THE TRAY HOWEVER IT WASN'T ENGAGED FULLY. TWO MORE ATTEMPTS WERE MADE TO IMPACT THE IMPLANT. NEW INSERT OF THE SAME TYPE WAS OPENED AND IMPACTED. NO ISSUES WERE REPORTED WITH THE SECOND INSERT. SURGERY WAS DELAYED 10 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150481 | ATTUNE CR FB INSRT SZ 7 8MM | ATTUNE IMPLANT : KNEE TIBIAL INSERT | JWH | DEPUY IRELAND - 9616671 | 1516-20-708 | J6443R | 10603295045915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |