FDA Adverse Event
Injury
Summary report: N
D/M GRIP AND 2 2.0MM HOMOG CBL
MDR report key: 2090905
·
Received May 12, 2011
Report
- Report Number
- 9616680-2011-00289
- Event Type
- Injury
- Date Received
- May 12, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 25, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- KTT
- PMA / PMN Number
- K872224
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
AN OPERATIVE SITE ADVERSE EVENT FOR CABLE GRIP LOOSENING WAS REPORTED FOR TRIDENT TITANIUM ACETABULAR SHELL REVISION STUDY SUBJECT (B)(4). IT WAS NOTED THAT THE SUBJECT HAD TROCHANTERIC PAIN DUE TO IRRITATION FROM THE CABLE GRIP AND THE DALL-MILES CABLE GRIP SYSTEM WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | D/M GRIP AND 2 2.0MM HOMOG CBL | IMPLANT | KTT | STRYKER ORTHOPAEDICS CORK | NA | 22339001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |