MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-11-20 for HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT 9M52-1535-W, 9095-0018-W manufactured by Arthrosurface, Inc..
[31702045]
Patient is experiencing pain on plantar flexion and complained of the same, during the two post-op follow up sessions with implanting surgeon. On visiting a second treating surgeon, patient recently learned that the implant is moving and is loosened. Efforts are being made by arthrosurface to understand the issues underlying the complaint. Discussions with another physician for second opinion are in progress. A supplemental report will be filed as required. Following are the details of the components that were implanted in patient. Part # 9m52-1535-w, lot # 75fc1006, mfg dt: 06/2013, exp dt: 06/2020. Part # 9095-0018-w, lot # 75jc1716, mfg dt: 10/2013, exp dt: 10/2018.
Patient Sequence No: 1, Text Type: N, H10
[31702046]
Patient contacted arthrosurface via website to report the pain being caused by hemicap that was implanted in the great toe since (b)(6) 2014. Patient questioned if implant could be loose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2015-00005 |
| MDR Report Key | 5238840 |
| Report Source | CONSUMER |
| Date Received | 2015-11-20 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-10-19 |
| Date Mfgr Received | 2015-10-19 |
| Date Added to Maude | 2015-11-20 |
| 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 | ARTHROSURFACE, INC. |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT |
| Generic Name | TOE JOINT PHALANGEAL (HEMI-TOE) POLYMER PROSTHESIS |
| Product Code | KWD |
| Date Received | 2015-11-20 |
| Catalog Number | 9M52-1535-W, 9095-0018-W |
| Lot Number | 75FC1006, 75JC1716 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2015-11-20 |