MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-17 for CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT manufactured by Arthrosurface, Inc..
[89514040]
The exact cause of the reported pain cannot be ascertained with the information available. However, according to patient's treating surgeon, she developed an osteophyte around the implant which may be a contributor to the reported pain. As no implant specific information was provided, review of manufacturing or performance history of the subject implant lot cannot be performed. The patient was advised to consult her original physician who implanted hemicap to discuss her current issues and assess her toe. No further information was received by arthrosurface to date from the patient.
Patient Sequence No: 1, Text Type: N, H10
[89514041]
The patient reached out to arthrosurface via website to report pain in her toe. There was no pain relief since the toe joint replacement she had 7 years ago. Upon recent visit to a surgeon, she was told that she needs a revision as there is a bony growth around the implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00022 |
| MDR Report Key | 6955441 |
| Report Source | CONSUMER |
| Date Received | 2017-10-17 |
| Date of Report | 2017-09-18 |
| Date Mfgr Received | 2017-09-18 |
| Date Added to Maude | 2017-10-17 |
| 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 | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT |
| Generic Name | TOE JOINT, PHALANGEAL (HEMI-TOE) PROSTHESIS |
| Product Code | KWD |
| Date Received | 2017-10-17 |
| 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 | 2017-10-17 |