DELTA CER FEM HD 32/+6MM T1
Report
- Report Number
- 3002806535-2019-00740
- Event Type
- Injury
- Date Received
- September 11, 2019
- Date of Event
- July 29, 2018
- Report Date
- December 13, 2019
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT: STANMORE LATERAL SZ 4 CATALOG #: 650-0943 LOT #: 2041864. MEDICAL PRODUCT: EXCEED CEMENTED MULLER E1 60 CATALOG #: EP-123260 LOT #: 3864690. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THE HOSPITAL REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT PROCEDURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO THE CERAMIC FEMORAL HEAD FRACTURING.
THE HOSPITAL REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT PROCEDURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO THE CERAMIC FEMORAL HEAD FRACTURING.
THE HOSPITAL REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT PROCEDURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO THE CERAMIC FEMORAL HEAD FRACTURING.
THE HOSPITAL REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT PROCEDURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO THE CERAMIC FEMORAL HEAD FRACTURING.
(B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN THE (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: STANMORE LATERAL SZ 4, CATALOG #: NOT REPORTED, LOT #: NOT REPORTED; MEDICAL PRODUCT: EXCEED CEMENTED MULLER E1 60, CATALOG #: NOT REPORTED, LOT #: NOT REPORTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.
THE HOSPITAL REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT PROCEDURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO THE CERAMIC FEMORAL HEAD FRACTURING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 791476 | DELTA CER FEM HD 32/+6MM T1 | KNEE PROSTHESIS | NRA | BIOMET UK LTD. | N/A | 2019020673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |