FDA Adverse Event
Injury
Summary report: N
BHR ACETABULAR CUP 60MM
MDR report key: 8349238
·
Received February 19, 2019
Report
- Report Number
- 3005975929-2019-00072
- Event Type
- Injury
- Date Received
- February 19, 2019
- Date of Event
- October 30, 2018
- Report Date
- June 18, 2019
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD
- Product Code
- NXT
- UDI-DI
- 03596010502612
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. - ATTACHMENT: [233434 SUMMARY.PDF]
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A LOOSENING OF THE ACETABULAR CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142128 | BHR ACETABULAR CUP 60MM | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 093398 | 03596010502612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | FEMORAL HEAD, PART # 74121154, LOT # 082528 028| FEMORAL HEAD, PART # 74121154, LOT # UNKNOWN| FEMORAL HEAD, PART # 74121154, LOT # UNKNOWN |