FDA Adverse Event
Injury
Summary report: N
PIN LNR CONS NEUT +4 36IDX60OD
MDR report key: 1983031
·
Received February 7, 2011
Report
- Report Number
- 1818910-2011-01781
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 4, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWZ
- PMA / PMN Number
- K043058
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
CONSTRAINED LINER BROKE DOWN AND PT DISLOCATED. PT WEIGHS (B)(6) LBS. POLY WEAR AND OSTEOLYSIS WERE ALSO REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIN LNR CONS NEUT +4 36IDX60OD | 87KWZ | KWZ | DEPUY ORTHOPAEDICS, INC. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |