MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-08-22 for CAP - GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT manufactured by Arthrosurface, Inc..
[83249537]
Arthrosurface has limited information regarding this case from the source document received. The device was not returned for investigation. As no part number and lot number were provided, the manufacturing history of implant device(s) installed in the patient could not be reviewed. A cause for this specific event cannot be ascertained from the information provided. If additional information becomes available, a supplemental mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[83249538]
Arthrosurface was notified of the information that a patient implanted with toe hemicap underwent revision surgery on (b)(6) 2017 due to chronic pain in his toe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00011 |
| MDR Report Key | 6810712 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-08-22 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-07-26 |
| Date Added to Maude | 2017-08-22 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2017-08-22 |
| 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 | 2017-08-22 |