ATTUNE CR RP INSRT SZ 7 6MM
Report
- Report Number
- 1818910-2019-95839
- Event Type
- Injury
- Date Received
- June 12, 2019
- Date of Event
- January 14, 2019
- Report Date
- May 16, 2019
- Manufacturer
- DEPUY IRELAND 9616671
- Product Code
- NJL
- UDI-DI
- 10603295047995
- PMA / PMN Number
- P830055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTED DATE IN REPORT.
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.
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. PRODUCT COMPLAINT # (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT =PRODUCT CODE 151630706, WORK ORDER 7832224 WAS MANUFACTURED ON 22/JAN/14. (B)(4) PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE IS ONE DEVIATION ASSOCIATED WITH THIS LOT NR-0102929. THIS IS A PRODUCT DEVIATION FOR SURFACE FINISH OUT-OF-SPECIFICATION WHICH WAS INVESTIGATED UNDER PRODUCT ISSUE ASSESSMENT (PIA) - PIA NUMBER 1236841. THE PIA OUTCOME WAS LOW/NO PATIENT IMPACT AND THE BATCH WAS DISPOSITIONED AS ¿USE AS IS¿. THERE IS NO CORRELATION BETWEEN THIS DEVIATION AND THE FAILURE MODE. 4 PIECES WERE SCRAPPED FROM WORK ORDER 7832224 AT M/C: LTHE0053, 3 PARTS WITH SCRAP CODE A564, FOR PART MARK 2D MARK SCRAP AND 1 PART WITH SCRAP CODE A129 FOR MACHINING SCRAP. THERE IS NO CORRELATION BETWEEN THE SCRAP AND THE FAILURE MODE OF THE COMPLAINT. DEVICE HISTORY BATCH = NULL. DEVICE HISTORY REVIEW = NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, ON (B)(6) 2019, THE PATIENT PRESENTED FOR AN EVALUATION OF THE LEFT KNEE DUE TO INSTABILITY, PAIN, AND RECURRENT FALLS. THE SURGEON NOTED A PLAN TO REVISE THE FEMORAL COMPONENT AS WELL AS THE TIBIAL INSERT, AND HOPEFULLY RETAIN THE TIBIAL COMPONENT. HOWEVER, THE REVISION OPERATIVE NOTES WERE NOT AVAILABLE AT THE TIME OF REVIEW. THE STICKER SHEET FOR THE REVISION OPERATION ON (B)(6) 2019 WAS REVIEWED AND ONLY SHOWED A TIBIAL INSERT WAS EXCHANGED.
(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
CLINICAL NOTIFICATION RECEIVED FOR LEFT KNEE REVISION TO ADDRESS INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2019; (LEFT KNEE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 483898 | ATTUNE CR RP INSRT SZ 7 6MM | ATTUNE IMPLANT : KNEE TIBIAL INSERT | NJL | DEPUY IRELAND 9616671 | 7832224 | 10603295047995 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |