ATTUNE CR FB INSRT SZ 7 5MM
Report
- Report Number
- 1818910-2022-03757
- Event Type
- Injury
- Date Received
- February 28, 2022
- Date of Event
- February 15, 2022
- Report Date
- February 28, 2022
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- NJL
- UDI-DI
- 10603295045885
- PMA / PMN Number
- K101433
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(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). 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). 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.
(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)(6). INVESTIGATION SUMMARY: AN 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.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LATERAL AND ANTERIOR PAIN. SHE HAD FALLEN A COUPLE TIMES. THE PATIENT WAS BROUGHT BACK FOR SURGERY AND A LATERAL RELEASE WAS COMPLETED. THE POLY WAS UPSIZED FROM A SIZE 7 X 5MM TO A SIZE 7 X 6MM. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT "A. WAS THE PRODUCT IMPLANTED USING DEPUY SYNTHES ATTUNE FEMUR FIRST ANATOMIC ALIGNMENT SURGICAL TECHNIQUE (DSUS/JRC/0617/2179) OR THE ATTUNE ANATOMIC TIBIA BALANCED FEMUR SURGICAL TECHNIQUE (097081-180816 DSEM)? FEMUR FIRST ANATOMIC TECHNIQUE WAS USED. "
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LATERAL AND ANTERIOR PAIN. SHE HAD FALLEN A COUPLE TIMES. THE PATIENT WAS BROUGHT BACK FOR SURGERY AND A LATERAL RELEASE WAS COMPLETED. THE POLY WAS UPSIZED FROM A SIZE 7 X 5MM TO A SIZE 7 X 6MM. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 883084 | ATTUNE CR FB INSRT SZ 7 5MM | ATTUNE IMPLANT : KNEE TIBIAL INSERT | NJL | DEPUY IRELAND - 9616671 | 1516-20-705 | J95A29 | 10603295045885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention |