FDA Adverse Event
Injury
Summary report: N
ZIMMER
MDR report key: 1062602
·
Received June 18, 2008
Report
- Report Number
- 1822565-2008-00333
- Event Type
- Injury
- Date Received
- June 18, 2008
- Date of Event
- February 28, 2008
- Report Date
- May 19, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2007. POST-OP IN 2008, THE SURGEON SAID MOVEMENT OF THE DEVICE CONSTRUCT DURING AMBULATION WITH PULLING FRACTURE ZONE APART. REVISION SURGERY OCCURRED THE FOLLOWING MONTH, DUE TO FRACTURE OF THE LAG SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER | FREE-LOCK LAG SCREW, STD, THD | HWC | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| R |