FDA Adverse Event
Injury
Summary report: N
ACETABULAR LINER
MDR report key: 843413
·
Received April 26, 2007
Report
- Report Number
- 2249697-2007-00054
- Event Type
- Injury
- Date Received
- April 26, 2007
- Date of Event
- February 26, 2007
- Report Date
- March 30, 2007
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KBW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MDR REPORT # 2249697-2007-00039. DEVICE NOT REC'D, NO EVAL WILL BE PERFORMED. IF THE DEVICE BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
THE FACILITY REPORTED ON BEHALF OF THE CUSTOMER THAT THE PT UNDERWENT A REVISION OF ACETABULAR LEFT TOTAL HIP REPLACEMENT. IT IS REPORTED THAT THE HIP WAS DISLOCATED AND THE SURGEON REMOVED THE HEAD FROM THE RESTORATION STEM AND REPLACED THE LINER FROM THE TRIDENT SHELL AND INSERTED A CONSTRAINED LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACETABULAR LINER | IMPLANT | KBW | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |