FDA Adverse Event
Injury
Summary report: N
ALUMINA V40-FEMORAL HEAD 32 MM, +0MM NK
MDR report key: 1060380
·
Received June 12, 2008
Report
- Report Number
- 9616680-2008-00150
- Event Type
- Injury
- Date Received
- June 12, 2008
- Date of Event
- September 11, 2007
- Report Date
- May 16, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K023901
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE SAME PT AND EVENT AS REPORT # 9616680-2008-00149.
Description of Event or Problem · 1
IN THE FRAMEWORK OF A CLINICAL STUDY, WE REC'D A LETTER FROM THE SURGEON STATING THE FOLLOWING: PRIMARY SURGERY WAS IN 2004. AFTER SIX WEEKS, A CUP MIGRATION WAS VISIBLE IN THE X-RAY. THE PT SENSED NO PAIN. UNDER MOBILIZATION WITHOUT PUTTING PRESSURE ON IT THE MIGRATION STOPPED. IN 2007, A SQUEAKING WAS MENTIONED. THE PT STILL HAD NO PAIN. AS THIS WAS A PROBLEM FOR THE PT, THE SURGEON DECIDED TO PERFORM A REVISION OF THE HEAD AND THE INLAY AT APPROXIMATELY 5 MONTHS LATER. THE STEM WAS NOT REVISED. UNTIL NOW THE PT IS PAIN FREE UNDER FULL MOBILIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALUMINA V40-FEMORAL HEAD 32 MM, +0MM NK | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | 10334302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |