FDA Adverse Event
Injury
Summary report: N
ACCU-PATH ACETABULAR SHELL
MDR report key: 47567
·
Received November 5, 1996
Report
- Report Number
- 2219689-1996-00192
- Event Type
- Injury
- Date Received
- November 5, 1996
- Date of Event
- October 7, 1996
- Report Date
- November 4, 1996
- Manufacturer
- HOWMEDICA, INC.
- Product Code
- KWB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SUMMARY OF EVALUATION: THE COMPONENT CAN NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED TO CO. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN UNSUCCESSFUL. THE DEVICE HISTORY RECORDS FOR THE COMPONENTS WERE REVIEWED AND NO DISCREPANCIES WERE OBSERVED.
Description of Event or Problem · 1
REPORTER STATED, REVISION SURGERY REVEALED LOOSENING OF THE ACETABULAR SHELL. THE SUPERIOR PORTION OF THE ACETABULAR INSERT ROTATED INFERIORLY INSIDE THE SHELL ALLOWING DISLOCATION. BOTH COMPONENTS WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-PATH ACETABULAR SHELL Implant | ARTIFICIAL HIP COMPONENT | KWB | HOWMEDICA, INC. | NA | JOHEB1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | FEMORAL STEM COMPONENT-WELL FIXED| AND REMAINED IMPLANTED |