DELTA CER HEAD 12/14 36MM +8.5
Report
- Report Number
- 1818910-2023-12907
- Event Type
- Malfunction
- Date Received
- June 23, 2023
- Date of Event
- June 12, 2023
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LZO
- UDI-DI
- 10603295033639
- PMA / PMN Number
- P070026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE FOUND THAT THE PATIENT AND CARTON LABELS FOR THE PACKAGED CERAMIC HEAD DID NOT MATCH; DIFFERENT PRODUCT CODES AND LOT NUMBERS WERE OBSERVED. HOWEVER, THE REPORTED COMPLAINT CONDITION CANNOT BE TRACED TO A MANUFACTURING ISSUE. 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 WAS PERFORMED FOR THE FINISHED DEVICE [136536330 / 3999262] AND [136536320 / 4151745], AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING MANUFACTURING.
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). 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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED ON (B)(6) 2023, THAT SURGEON ASKED FOR A 36 + 5 CERAMIC HEAD DURING A TOTAL HIP REPLACEMENT SURGERY. A SALES REPRESENTATIVE VERBALLY CONFIRMED PRODUCT CONTENTS FROM OUTER BOX AND HANDED A SEALED/CLOSED BOX TO NURSE. THE NURSE OPENED THE BOX, REMOVED THE IMPLANT STICKERS, AND DISCOVERED THEY WERE 36 +8.5, NOT 36 +5 AS THE BOX DESCRIBED. THE IMPLANT WAS NOT OPENED, AND INSTEAD ANOTHER 36 +5 BOX WAS OPENED AFTER CONTENTS WERE CONFIRMED TO BE A MATCH WITH THE BOX DESCRIPTION. NO SURGICAL DELAY. THIS REPORT IS FOR DELTA CER HEAD 12/14 36MM +8.5 THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 749615 | DELTA CER HEAD 12/14 36MM +8.5 | ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS | LZO | DEPUY ORTHOPAEDICS INC US | 1365-36-330 | 3999262 | 10603295033639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | DELTA CER HEAD 12/14 36MM +5. |