FDA Adverse Event
Injury
Summary report: N
UNKNOWN #3 PCA STEM
MDR report key: 2170044
·
Received July 13, 2011
Report
- Report Number
- 2249697-2011-01040
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 21, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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. ADDITIONAL INFO INCLUDING CATALOG NUMBER, LOT CODE, IMPLANT DATE, X-RAYS, OPERATIVE REPORTS AND MEDICAL RECORDS WERE REQUESTED, BUT NOT PROVIDED. IF ADDITIONAL INFO SHOULD BECOME AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "STEM LOOSENED AND NEEDED TO BE REPLACED. STEM WAS TAKEN OUT AND REPLACED WITH A LONG STEM, MODULAR RESTORATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN #3 PCA STEM | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other| R |