ATTUNE PS FB INSRT SZ 6 5MM
Report
- Report Number
- 1818910-2022-01345
- Event Type
- Malfunction
- Date Received
- January 21, 2022
- Date of Event
- January 11, 2022
- Report Date
- January 21, 2022
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- NJL
- UDI-DI
- 10603295050063
- PMA / PMN Number
- K111433
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. PHOTOGRAPHIC EVIDENCE REVIEW WAS NOT ABLE TO CONFIRM THE COMPLAINT. VISUAL EXAMINATION OF THE RETURNED IMPLANT FOUND NO DEFECTS ON THE PART. IT IS NOT POSSIBLE TO CONFIRM THE COMPLAINT AS THE MATING DEVICE WAS NOT RETURNED FOR FUNCTIONAL TESTING. 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 SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION DEVICE HISTORY REVIEW: A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. CORRECTED: H3.
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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT DURING THE SURGERY, THE INSERT COULD NOT MATCH WITH PLATEAU. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
A. WAS THERE A SURGICAL DELAY? : NO. WHAT WAS THE DURATION OF THE DELAY? : NA. B. WAS THE PRODUCT IMPLANTED USING DEPUY SYNTHES¿S ATTUNE FEMUR FIRST ANATOMIC ALIGNMENT SURGICAL TECHNIQUE (DSUS/JRC/0617/2179) OR THE ATTUNE ANATOMIC TIBIA BALANCED FEMUR SURGICAL TECHNIQUE (097081-180816 DSEM)? : ACCORDING TO FEEDBACK, THE PRODUCT IMPLANTED USED DEPUY SYNTHES¿S ATTUNE FEMUR FIRST ANATOMIC ALIGNMENT SURGICAL TECHNIQUE (DSUS/JRC/0617/2179).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 807298 | ATTUNE PS FB INSRT SZ 6 5MM | ATTUNE IMPLANT : KNEE TIBIAL INSERT | NJL | DEPUY IRELAND - 9616671 | 1516-40-605 | JF1181 | 10603295050063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |