FDA Adverse Event
Injury
Summary report: N
ACCOLADE TOTAL HIP SYSTEM
MDR report key: 1890023
·
Received November 1, 2010
Report
- Report Number
- 2249697-2010-01435
- Event Type
- Injury
- Date Received
- November 1, 2010
- Date of Event
- May 12, 2008
- Report Date
- October 6, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWY
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION PROVIDED BY STRYKER ORTHOPAEDICS CLINICAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
CLINICAL DEPARTMENT RECEIVED DELIVERABLE WHICH WAS INDICATED AS A CONTRACT MILESTONE FROM THE SITE WITH INFORMATION ON FOLLOW UP APPOINTMENTS. THE SPREAD SHEET IDENTIFIED SUBJECTS WHO REQUIRED REVISIONS FOLLOWING THA. LEFT REVISION (B)(6) 2008 INFECTION. SURGERY DATE (B)(6) 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE TOTAL HIP SYSTEM | IMPLANT | KWY | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other| R |