FDA Adverse Event
Malfunction
Summary report: N
TRIDENT 0 DEG CONSTRAINED INSERT 28G
MDR report key: 1981647
·
Received January 12, 2011
Report
- Report Number
- 2249697-2011-00037
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- September 10, 2010
- Report Date
- December 16, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWZ
- PMA / PMN Number
- K061654
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PUT IN ALL THE IMPLANTS AND SNAPPED THE HEAD INTO THE CONSTRAINED LINER WENT THROUGH FINAL RANGE OF MOTION AT WHICH POINT IT WAS DISCOVERED THAT THE CONSTRAINED LINER WAS NOT ENGAGED INTO THE LOCKING MECHANISM. AT WHICH POINT SURGEON DID NOT WANT TO REUSE THE IMPLANT FOR FEAR OF DAMAGED MECHANISM. A REPLACEMENT WAS USED IN THE PLACE OF IT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 0 DEG CONSTRAINED INSERT 28G | IMPLANT | KWZ | STRYKER ORTHOPAEDICS MAHWAH | NA | T0PMPA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |