FDA Adverse Event
Injury
Summary report: N
PREM PLUS HIP SYSTEM
MDR report key: 2170045
·
Received July 13, 2011
Report
- Report Number
- 2249697-2011-01039
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K910869
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SURGEON COMMENTED PT WAS A CHRONIC DISLOCATOR. STEM WAS LOOSE. SURGEON EXTRACTED CEMENTED OMNIFIT HFX STEM AND EXCHANGED LINER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREM PLUS HIP SYSTEM | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | C3WHP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |