FDA Adverse Event
Injury
Summary report: N
32HD MED NK SM T/H STEM HARRI
MDR report key: 1942481
·
Received December 22, 2010
Report
- Report Number
- 2249697-2010-01893
- Event Type
- Injury
- Date Received
- December 22, 2010
- Date of Event
- November 30, 2010
- Report Date
- November 30, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K780317
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2010-01894.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "CUP AND STEM WERE LOOSE. DR REVISED THEM AND WAS SATISFIED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 32HD MED NK SM T/H STEM HARRI | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | GXB4C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Other| R |