FDA Adverse Event
Injury
Summary report: N
HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
MDR report key: 7146780
·
Received December 26, 2017
Report
- Report Number
- 3004154314-2017-00028
- Event Type
- Injury
- Date Received
- December 26, 2017
- Report Date
- November 28, 2017
- Manufacturer
- ARTHROSURFACE, INC.
- Product Code
- KWD
- PMA / PMN Number
- K131377
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE EXACT CAUSE FOR THE PATIENT'S ISSUES IS UNKNOWN. THE MTP HEMICAP DEVICE REMAINS IMPLANTED IN THE PATIENT AND WILL NOT BE RETURNED. THEREFORE NO PRODUCT EVALUATION IS CONDUCTED. NO X-RAYS, SCANS, PICTURES, PHYSICIAN'S REPORTS ETC. ,WERE PROVIDED. PATIENT IS CURRENTLY SEEKING A SECOND OPINION WITH A SURGEON REFERRED BY ARTHROSURFACE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
Description of Event or Problem · 1
THE PATIENT REACHED OUT TO ARTHROSURFACE VIA WEBSITE TO COMPLAIN THAT SHE CONTINUES TO HAVE PAIN AND SWELLING AFTER RECEIVING HEMICAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 924565 | HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT | MTP HEMI-TOE PROSTHESIS | KWD | ARTHROSURFACE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |