MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-14 for HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY manufactured by Arthrosurface, Inc..
[86146375]
Three attempts were made to contact the patient by arthosurface regional manager in her area. No response was received. An investigation cannot be conducted as patient's clinical history or her implant information is currently unavailable. Should any additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
[86146376]
The patient reached out to arthrosurface via website to inquire about list of surgeons in her area. Per initial information relayed to arthrosurface, she received an arthrosurface toe implant in (b)(6) 2017 and since has been experiencing pain and swelling in the joint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00019 |
| MDR Report Key | 6865194 |
| Report Source | CONSUMER |
| Date Received | 2017-09-14 |
| Date of Report | 2017-08-15 |
| Date of Event | 2017-05-26 |
| Date Mfgr Received | 2017-08-15 |
| Date Added to Maude | 2017-09-14 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 3 |
| Brand Name | HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY |
| Generic Name | MTP HEMI-TOE PROSTHESIS |
| Product Code | KWD |
| Date Received | 2017-09-14 |
| 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; 2. Deathisabilit | 2017-09-14 |