FDA Adverse Event
Injury
Summary report: N
TRIDENT 0 DEG CONSTRAINED INSERT 28G
MDR report key: 2142431
·
Received June 21, 2011
Report
- Report Number
- 2249697-2011-00926
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- May 20, 2011
- Report Date
- June 1, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWZ
- PMA / PMN Number
- K061654
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE C-TAPER COCR LFIT HEAD 28MM/-3; CAT# 06-2898, LOT# MHAN70 WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PRODUCT LUXATION. AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO (INCLUDING X-RAYS 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 HAS BEEN REPORTED THAT: SURGERY (B)(6) 2011 (APPROX.). PT WAS DISCHARGED FROM HOSPITAL. WHILE HE WENT TO CHEMOTHERAPY SESSIONS, THERE WAS A PRODUCT LUXATION. SURGERY (B)(6) 2011(APPROX.): THE REF. (B)(4) WERE EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 0 DEG CONSTRAINED INSERT 28G | IMPLANT | KWZ | STRYKER ORTHOPAEDICS MAHWAH | NA | MHDALN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |