FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT - HEAD
MDR report key: 2032695
·
Received March 17, 2011
Report
- Report Number
- 9616680-2011-00138
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- January 18, 2011
- Report Date
- March 1, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 9616680-2011-000137.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SQUEAKING SOUND AND INTRA-ARTICULAR HYDROPS WERE OCCURRED AFTER THA WITH ACCOLADE, TRI-AD AND CERAMIC LINER, SO, THE HEAD AND LINER WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT - HEAD | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |