FDA Adverse Event
Malfunction
Summary report: N
UNK PRODUCT - CUSTOM HIP IMPACTOR
MDR report key: 2191436
·
Received July 28, 2011
Report
- Report Number
- 2249697-2011-01133
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- May 10, 2011
- Report Date
- July 6, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- 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. ADD'L INFO HAS BEEN REQUESTED AND IF IT BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "NEW, NON MODULAR CUSTOM INSTRUMENTS ALLOWED THE SHELL AND INSTRUMENT CONSTRUCT TO FALL OFF THE SHELL POSITIONER. THIS RESULTED IN SURGEON REQUESTING AN IMPROVED IMPACTOR. SHELL STAYED IN STERILE FIELD AND FINALLY INSERTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK PRODUCT - CUSTOM HIP IMPACTOR | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |