MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-30 for HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY manufactured by Arthrosurface, Inc..
[104027447]
The manufacturer is currently investigating the issue and will submit the results in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[104027448]
In a patient, bone resorption was noticed behind the toe hemicap implant during revision surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2018-00008 |
| MDR Report Key | 7386770 |
| Date Received | 2018-03-30 |
| Date of Report | 2018-03-01 |
| Date Mfgr Received | 2018-03-01 |
| Date Added to Maude | 2018-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PHANI PUPPALA |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal | 02038 |
| Manufacturer Phone | 5085203003 |
| Manufacturer G1 | PRIMO MEDICAL GROUP |
| Manufacturer Street | 75 MILL ST |
| Manufacturer City | STOUGHTON MA 02072 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY |
| Generic Name | MTP HEMI-TOE PROSTHESIS |
| Product Code | KWD |
| Date Received | 2018-03-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROSURFACE, INC. |
| Manufacturer Address | 28 FORGE PARKWAY FRANKLIN MA 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-30 |