FDA Adverse Event
Injury
Summary report: N
TRIATHLON P/A CR BEADED #5R
MDR report key: 2234050
·
Received August 29, 2011
Report
- Report Number
- 9610726-2011-00302
- Event Type
- Injury
- Date Received
- August 29, 2011
- Date of Event
- June 21, 2010
- Report Date
- August 11, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- MBH
- PMA / PMN Number
- K051380
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT HAS BEEN EXPERIENCING SWELLING, PAIN AND A CLICKING NOISE UPON WALKING. HE HAS REACHED OUT TO HIS SURGEON BUT RECENTLY THE SURGEON HAS BEEN UNABLE. PT WANTS TO KNOW IF HIS IMPLANTS HAVE BEEN SUBJECT TO ANY RECALLS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON P/A CR BEADED #5R | IMPLANT | MBH | STRYKER ORTHOPAEDICS LIMERICK | NA | EEXH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |