FDA Adverse Event
Injury
Summary report: N
PINNACLE MTL INS NEUT40IDX56OD
MDR report key: 2945549
·
Received February 6, 2013
Report
- Report Number
- 1818910-2013-11954
- Event Type
- Injury
- Date Received
- February 6, 2013
- Date of Event
- February 20, 2012
- Report Date
- January 25, 2013
- Manufacturer
- DEPUY INTL., LTD.
- Product Code
- KWA
- PMA / PMN Number
- PK062426
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THIS IS A DUPLICATE REPORT OF 1818910-2012-06429. THIS REPORT, 1818910-2013-11954, WILL BE REJECTED. 1818910-2012-06429 WILL BE KEPT FOR INVESTIGATION PURPOSES.
Description of Event or Problem · 1
(B)(4) VOLUNTARILY SUBMITTED BY PATIENT STATES THAT THEY WERE REVISED TO ADDRESS PAIN AND ELEVATED CHROMIUM AND COBALT LEVELS, WHICH CAUSED DETERIORATION OF THE BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50521 | PINNACLE MTL INS NEUT40IDX56OD | ACETABULAR LINER | KWA | DEPUY INTL., LTD. | 2586970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |