FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD MCK 8DEG 38MM
MDR report key: 3162179
·
Received May 31, 2013
Report
- Report Number
- 9616680-2013-90161
- Event Type
- Injury
- Date Received
- May 31, 2013
- Date of Event
- January 1, 2010
- Report Date
- May 22, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K092561
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, PT IS EXPERIENCING PAIN SINCE THE SURGERY AND IS GETTING WORSE SINCE (B)(6) OF 2011. HE HAS BEEN ON PAIN MEDICATIONS AND THE FENTANYL PATCH. HE IS FOLLOWING WITH HIS SURGEON AND PRIMARY PHYSICIAN. HE WILL HAVE AN MRI AND BLOOD WORK. INFORMATION PROVIDED BY THE SALES REP ON (B)(6) 2013 INDICATED THAT THE PT HAD ALTR IN THE RIGHT HIP POST PRIMARY SURGERY. BASED ON THE PT'S EXAM, LAB AND IMAGING RESULTS. THE SURGEON REVIEWED PT'S RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240496 | LRG TAP PRI MOD MCK 8DEG 38MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | 23328101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other| R |