MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT manufactured by Arthrosurface, Inc..
[162991838]
The patient is experiencing pain and believes joint fusion is his only option. Root cause of the pain was unable to be determined as necessary information to adequately investigate the reported event was not provided. Since the patient received implant more than 10 years ago, it is possible that the arthritis has progressed to the other side of the joint leading to generation of pain. Since no part and lot information was provided, review of the device history records (dhrs) of devices in question cannot be conducted. Arthrosurface advised the patient to visit his implanting surgeon or other surgeons in his network for diagnosis and finding out available options for his pain and other on-going issues. Arthrosurface is following-up with the patient and any additional information obtained from the patient will be reviewed for reportability and submitted via a supplemental mdr.
Patient Sequence No: 1, Text Type: N, H10
[162991839]
Patient received arthrosurface toe implant 10 years ago and is currently concerned about issues with the bone surrounding the implant. He wants to know if the issues were a result of the surgeon or the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2019-00013 |
| MDR Report Key | 9131797 |
| Date Received | 2019-09-27 |
| Date of Report | 2019-08-29 |
| Date Mfgr Received | 2019-08-29 |
| Date Added to Maude | 2019-09-27 |
| 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 | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT |
| Generic Name | TOE JOINT, PHALANGEAL (HEMI-TOE) PROSTHESIS |
| Product Code | KWD |
| Date Received | 2019-09-27 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-09-27 |