ATTUNE CR RP INSRT SZ 7 5MM
Report
- Report Number
- 1818910-2021-26607
- Event Type
- Injury
- Date Received
- December 1, 2021
- Date of Event
- November 8, 2021
- Report Date
- December 1, 2021
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- NJL
- UDI-DI
- 10603295047988
- PMA / PMN Number
- P830055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 : 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). 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 : DHR REVIEW WAS PERFORMED : DETAILS ARE AS FOLLOWS. 1) QUANTITY MANUFACTURED: 18 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION 2) DATE OF MANUFACTURE: 05-JUNE-2018 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: 1 NONCONFORMANCE IS ASSOCIATED WITH THIS LOT: NR-0102929 IS RELATED TO AN ISSUE IDENTIFIED WITH THE SURFACE FINISH OF THE PARTS WHEN CARRYING OUT IN-PROCESS FIRST OFF SURFACE FINISH INSPECTIONS AT THE MACHINE STEP AS PER SWS-0003 (ATTUNE CR INSERTS MACHINE & INSPECT, REV. 18) AND TM-100743 (PART CONDITION & SURFACE FINISH INSPECTION - ATTUNE INSERTS, REV. 7). PRODUCT ISSUE ASSESSMENT (PIA) 1236841 OUTCOME WAS LOW/ NO PATIENT IMPACT. ALL PRODUCTS WERE DISPOSITIONED AS ¿USE AS IS¿. THERE IS NO CORRELATION BETWEEN THIS NON-CONFORMANCE AND THE FAILURE MODE OF THE COMPLAINT. 4) EXPIRY DATE: 31 MAY 2023 5) IFU REFERENCE: (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.
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. H11 ADDITIONAL NARRATIVE: ADDED: B5, D3 (MANUFACTURER EMAIL), D10 (CONCOMITANT). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
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.
CLINICAL DATABASE SPECIFIES FEMORAL STEM, TIBIAL INSERT, TIBIAL BASE, TIBIAL STEM, AND TIBIAL SLEEVE WERE REMOVED. ALL THE PRIMARY IMPLANTS WILL BE CODED FOR INFECTION. THE NEWLY REVISED INSERT WILL NOT BE CODED AS INFECTION AS IT IS NOT LIKELY TO HAVE CONTRIBUTED TO THE ORIGINAL INFECTION.
ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED): YES.
(B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOW GRADE INFECT OF THE LEFT KNEE EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: IRRIGATION & DEBRIDEMENT WITH REVISION INSERT EXCHANGE ON (B)(6) 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259356 | ATTUNE CR RP INSRT SZ 7 5MM | ATTUNE IMPLANT : KNEE TIBIAL INSERT | NJL | DEPUY IRELAND - 9616671 | 1516-30-705 | 8825424 | 10603295047988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Male | Required Intervention | ATTUNE CR FEM LT SZ 7 CEM| ATTUNE CR FEM LT SZ 7 CEM| ATTUNE CR RP INSRT SZ 7 5MM| ATUN TIB SLV M/L 37MM HALF POR| ATUN TIB SLV M/L 37MM HALF POR| ATUNE PRESSFIT STR STEM16X60MM| ATUNE PRESSFIT STR STEM16X60MM| ATUNE REV RP TIB BASE SZ 5 CEM| ATUNE REV RP TIB BASE SZ 5 CEM| SMARTSET GHV GENTAMICIN 20G| SMARTSET GHV GENTAMICIN 20G| SMARTSET GHV GENTAMICIN 40G| SMARTSET GHV GENTAMICIN 40G| UNK ATTUNE KNEE TIBIAL INSERT |