FDA Adverse Event
Injury
Summary report: N
ZIMMER VERSYS FEMORAL STEM
MDR report key: 6116589
·
Received November 21, 2016
Report
- Report Number
- 0002648920-2016-03288
- Event Type
- Injury
- Date Received
- November 21, 2016
- Report Date
- May 12, 2017
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- LWJ
- PMA / PMN Number
- PK955473
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI - NOT APPLICABLE. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative · 1
UDI: (B)(4).
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT IS BEGINNING TO EXPERIENCE PAIN FOLLOWING A PARTIAL HIP ARTHROPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 768995 | ZIMMER VERSYS FEMORAL STEM | HIP PROSTHESIS | LWJ | ZIMMER MANUFACTURING B.V. | N/A | 62969729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |