FDA Adverse Event
Injury
Summary report: N
C-TAPER COCR LFIT HEAD 28MM/+5
MDR report key: 2162188
·
Received July 7, 2011
Report
- Report Number
- 2249697-2011-01019
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 20, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K91088
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 (INCLUDING X-RAYS, PATHOLOGY REPORTS AND MEDICAL RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT HAD INFECTION, DEBRIDEMENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-TAPER COCR LFIT HEAD 28MM/+5 | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | MJK3XP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other| R |