MODULAR FEMORAL STEM PLASMA CEMENTLESS SIZE 7.5
Report
- Report Number
- 0001822565-2019-04140
- Event Type
- Injury
- Date Received
- September 24, 2019
- Report Date
- February 2, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- LZO
- PMA / PMN Number
- K063251
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: CAT#: 1217-20-050 DEPUY CUP LOT#: 835FCI000. CAT#: 1221-32-450 DEPUY LINER LOT#: E1HAAI000. CAT#: 1217-30-500 DEPUY BONE SCREW LOT#: 430943. CAT#: 1217-20-500 DEPUY BONE SCREW LOT#: 432370.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRIMARY SURGERY NOTES PROVIDED STATE NO INTRAOPERATIVE COMPLICATIONS. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING FOR THE REPORTED PART AND LOT COMBINATIONS. ZIMMER BIOMET COMPONENTS WERE USED WITH COMPETITOR PRODUCTS AND IS NOT AN APPROVED COMBINATION TO BE USED. THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR/OFF LABEL USE. IT IS UNKNOWN IF THESE OFF-LABEL USAGES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN SHELL, PN: UNKNOWN LN: UNKNOWN; UNKNOWN LINER, PN: UNKNOWN LN: UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN HEAD, PN UNKNOWN, LN UNKNOWN. MDR: 0001822565-2019-04167. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY NINE YEARS AGO. SUBSEQUENTLY, IT IS ALLEGED PATIENT IS SUFFERING FROM PAIN AND OTHER UNKNOWN COMPLICATIONS AFTER IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 907582 | MODULAR FEMORAL STEM PLASMA CEMENTLESS SIZE 7.5 | PROSTHESIS, HIP | LZO | ZIMMER BIOMET, INC. | N/A | 61498046 | |
| 907617 | MODULAR FEMORAL STEM PLASMA CEMENTLESS SIZE 7.5 | PROSTHESIS, HIP | LZO | ZIMMER BIOMET, INC. | N/A | 61498046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |