FDA Adverse Event
Injury
Summary report: N
C-TAPER COCR LFIT HEAD 28MM/-3
MDR report key: 2151538
·
Received June 28, 2011
Report
- Report Number
- 2249697-2011-00961
- Event Type
- Injury
- Date Received
- June 28, 2011
- Date of Event
- June 4, 2011
- Report Date
- June 4, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K910988
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ASSOCIATED DEVICE: SYSTEM 12 28MM NEU DURATN INSERT P5, CATALOG # 6302-5-065, LOT # WDACA. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "PT WAS DISLOCATED AT HIP JOINT. 28MM LINER AND 28MM HEAD EXPLANTED REPLACED WITH 32MM 10 (DEGREE) AND 4 LINER AND 32MM HEAD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-TAPER COCR LFIT HEAD 28MM/-3 | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | 71731301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |