FDA Adverse Event
Malfunction
Summary report: N
ZIMMER SELF-TAPPING BONE SCREW
MDR report key: 6033104
·
Received October 17, 2016
Report
- Report Number
- 0002648920-2016-03215
- Event Type
- Malfunction
- Date Received
- October 17, 2016
- Date of Event
- September 1, 2016
- Report Date
- August 24, 2017
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- LPH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED AS ONLY THE PACKAGING WAS RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.
Description of Event or Problem · 1
IT IS REPORTED THE SCREW WAS MISSING FROM IT'S PACKAGING UPON RECEIPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 685456 | ZIMMER SELF-TAPPING BONE SCREW | HIP PROSTHESIS | LPH | ZIMMER MANUFACTURING B.V. | N/A | 62935949 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |