FDA Adverse Event
Injury
Summary report: N
ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5
MDR report key: 5683065
·
Received May 26, 2016
Report
- Report Number
- 0002249697-2016-01754
- Event Type
- Injury
- Date Received
- May 26, 2016
- Date of Event
- May 3, 2016
- Report Date
- November 12, 2025
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LPH
- UDI-DI
- 04546540510761
- PMA / PMN Number
- K994366
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. BASED ON THE LIMITED INFORMATION PROVIDED, THE EVENT COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY ON OR ABOUT (B)(6) 2011. A DIAGNOSTIC WORKUP ALLEGEDLY REVEALED THE PRESENCE OF INCREASED LEVELS OF METAL IONS, WHICH RESULTED IN A REVISION SURGERY ON UNKNOWN DATE. SUIT FILED IN (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337887 | ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5 | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | LPH | STRYKER ORTHOPAEDICS-MAHWAH | 35364602 | 04546540510761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Male | Hospitalization| R |