FDA Adverse Event
Injury
Summary report: N
HEMI HEAD 46MM
MDR report key: 8778113
·
Received July 10, 2019
Report
- Report Number
- 3005975929-2019-00268
- Event Type
- Injury
- Date Received
- July 10, 2019
- Date of Event
- July 11, 2017
- Report Date
- November 26, 2019
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS LTD
- Product Code
- NXT
- UDI-DI
- 03596010502780
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. 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, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. - ATTACHMENT: [255042 SUMMARY.PDF]
Description of Event or Problem · 0
CUP AND FEMORAL STEM RETAINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FAILED LEFT TOTAL HIP ARTHROPLASTY AND A SIGNIFICANT PSEUDOTUMOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569437 | HEMI HEAD 46MM | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 74122546 | 03596010502780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Hospitalization| R | ACETABULAR CUP, # 74120152, LOT # 75650| ANTHOLOGY SIZE 5 71356005/UNKNOWN LOT| FEMORAL STEM, # 71356005, LOT # 07FM00646| MODULAR SLEEVE, # 74222200, LOT # 07FW12482| UNKNOWN BHR CUP| UNKNOWN MODULAR SLEEVE| ANTHOLOGY SIZE 5 71356005/UNKNOWN LOT| UNKNOWN BHR CUP| UNKNOWN MODULAR SLEEVE |