FDA Adverse Event
Injury
Summary report: N
CONSTRAINED ACETABULAR INSERTS
MDR report key: 1233918
·
Received November 14, 2008
Report
- Report Number
- 2249697-2008-00366
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- October 22, 2008
- Report Date
- October 22, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWB
- PMA / PMN Number
- K890197
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO HAS BEEN REQUESTED. SHOULD DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE DEVICE WAS EXPLANTED FROM THE PATIENT BECAUSE THE INNER CONSTRAINED MECHANISM HAD SEPARATED FROM THE OUTER MECHANISM IN SITU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTRAINED ACETABULAR INSERTS | IMPLANT | KWB | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |