SEE H10 NARRATIVE
Report
- Report Number
- 0001822565-2023-01314
- Event Type
- Injury
- Date Received
- May 16, 2023
- Date of Event
- April 17, 2023
- Report Date
- August 16, 2023
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- SEE H10
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPON RECEIPT OF ADDITIONAL INFORMATION, THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. ONLY ONE FEMUR WAS IMPLANTED OUT OF TWO. THIS REPORT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 0001822565-2023-02176
(B)(4). D4 - TWO DEVICE IDS WERE PROVIDED BY THE REPORTER; OF THESE, ONLY ONE (1) WAS REPORTED TO HAVE METAL ALLERGY. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: ITEM#: 42504605401, LOT#: 65046024, MANUFACTURE DATE: MAY 24, 2021, STERILE EXPIRY DATE: MAY 17, 2031, UDI: (B)(4), 510K: K191625 PRO CODE: JWH. OR ITEM#: 42504605411 LOT#: 65046008, MANUFACTURE DATE: MAY 19, 2021, STERILE EXPIRY DATE: MAY 12, 2031, UDI: (B)(4), 510K: K191625 PRO CODE: JWH. D10 - MEDICAL PRODUCT: FEMORAL CENTRAL CONE, CATALOG # 42545001012, LOT# 64700341. TIBIA FIXED CEMENTED STEM EXTENSION, CATALOG # 42542006701, LOT# 64960941. STEM EXTENSION TAPERED CEMENTED, CATALOG # 4256007514, LOT# 65032365. STEM EXTENSION, CATALOG # 42560007514, LOT# 65033946. TIBIA CENTRAL CORE, CATALOG # 42545000511, LOT# 64815927. FEMUR CEMENTED, CATALOG # 42504605411, LOT# 65046008. STEM EXTENSION, CATALOG # 42560113510, LOT# 64911578. ARTICULAR SURFACE, CATALOG # 42512600414, LOT# 65321527. CABLE CERCLAGE CABLE, CATALOG # 00223200418, LOT # 65240317. CABLE CERCLAGE CABLE, CATALOG # 00223200418, LOT # 65240311. PALACOS R+G FAST, CATALOG # 66056768, LOT # 99571117. PALACOS R+G FAST, CATALOG # 66056768, LOT # 99571117. PALACOS R+G FAST, CATALOG # 66056768, LOT # 99571117. FEMALE HEX SCREW, CATALOG # 42509902525, LOT # 65259825. G2: AUSTRALIA. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001822565-2023-01299, 0001822565-2023-01300, 0001822565-2023-01301.
UPON RECEIPT OF ADDITIONAL INFORMATION, THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. ONLY ONE FEMUR WAS IMPLANTED OUT OF TWO. THIS REPORT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 0001822565-2023-02176
IT WAS REPORTED PATIENT IS EXPERIENCING ALLERGY TO METAL EIGHT MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1165199 | SEE H10 NARRATIVE | PROSTHESIS KNEE | JWH | ZIMMER BIOMET, INC. | N/A | SEE H10 NARRATIVE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |