FDA Adverse Event
Other
Summary report: N
FITMORE HIP STEM
MDR report key: 3202054
·
Received June 26, 2013
Report
- Report Number
- 9613350-2013-01669
- Event Type
- Other
- Date Received
- June 26, 2013
- Date of Event
- November 2, 2011
- Report Date
- June 14, 2013
- Manufacturer
- ZIMMER GMBH
- Product Code
- KWA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MFR DID NOT RECEIVED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT IS MONITORED AND HAS NOT BEEN REVISED TO DATE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SHOULD ADD'L INFO BECOME AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT UNDERWENT A TOTAL HIP ARTHROPLASTY IN HER RIGHT HIP, RECEIVING A FITMORE STEM ON (B)(6) 2010. AT 1 YEAR F/U, AS THE PT IS CURRENTLY MONITORED AND PAIN (MODERATE) WAS MENTIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290270 | FITMORE HIP STEM | FITMORE HIP STEM B EXT OFFS, SIZE 7 | KWA | ZIMMER GMBH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |