FDA Adverse Event
Injury
Summary report: N
TNDM BP SHL/XLPE LNR 41OD 26ID
MDR report key: 6055429
·
Received October 25, 2016
Report
- Report Number
- 1020279-2016-00819
- Event Type
- Injury
- Date Received
- October 25, 2016
- Date of Event
- April 13, 2016
- Report Date
- October 5, 2016
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.
Additional Manufacturer Narrative · 1
CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION, THE OUTER CUP REMAINED IN THE ACETABULUM. DURING REVISION SURGERY, IT WAS CONFIRMED THAT THE PLASTIC LOCK RING DETACHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 706394 | TNDM BP SHL/XLPE LNR 41OD 26ID | TANDEM BIPOLAR SHELL/XLPE LINER 41MM OD 26MM ID | JDH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| R | OXINIUM FEMORAL HEAD 12/14 26MM| SL-PLUS |