MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-02 for HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT manufactured by Arthrosurface, Inc..
[101465660]
The patient had 2 failed surgeries prior to receiving arthrosurface toe hemicap implant in (b)(6) 2016. After the surgery, she never got more than 15? Of dorsiflexion and is experiencing pain in the joint area. The reason for reported issues cannot be ascertained due to availability of limited information. Without part and lot information of the device(s) implanted, an investigation of the device history or performance cannot be conducted. There is no reasonable evidence from the information provided that arthrosurface device(s) had contributed to the reported pain and loss of motion. Arthrosurface has directed the patient to our website for additional physician information in case another opinion is desired. Any additional information received regarding this complaint will be reported through a supplemental mdr as necessary.
Patient Sequence No: 1, Text Type: N, H10
[101465661]
Patient reached out to arthrosurface via website to inquire if arthrosurface toemotion is an option after a failed hemicap. The patient stated that she never had adequate range of motion (rom) and currently experiencing pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2018-00005 |
| MDR Report Key | 7311222 |
| Date Received | 2018-03-02 |
| Date of Report | 2018-01-31 |
| Date Mfgr Received | 2018-01-31 |
| Date Added to Maude | 2018-03-02 |
| 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 IMPLANT |
| Generic Name | MTP HEMI-TOE PROSTHESIS |
| Product Code | KWD |
| Date Received | 2018-03-02 |
| 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 | 2018-03-02 |