MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT manufactured by Arthrosurface, Inc..
[141014098]
A definitive root cause cannot be determined with the information provided. The device history records were reviewed indicating the devices were manufactured, inspected and packaged to specification. Since the patient started to feel pain 3 years after surgery, it is possible that the arthritis may have progressed to the other side of the joint. No other complaints or reports concerning pain or other adverse events were reported for the part lots in question. As requested by the patient, local surgeon information was provided for obtaining a secondary opinion. The following is the lot info of implant components received by the patient. Pn: 9095-0018-w lot: 75ek0313 mfg. Date: 05/2011 exp. Date: 05/2016; pn: 9m52-2535-w lot: 75dk0534 mfg. Date: 04/2011 exp. Date: 04/2016. Any further information received from the patient will be documented in the complaint file and reviewed for reporting through a supplemental mdr.
Patient Sequence No: 1, Text Type: N, H10
[141014099]
Patient received a toe df implant in (b)(6) 2011 and started to feel pain after 3 years of implantation. On consulting a new podiatrist, she was told her only option is to fuse the mtp joint. The patient is currently experiencing excruciating pain and wants to know if implantation of a phalangeal component would help.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2019-00001 |
| MDR Report Key | 8485160 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-03-08 |
| Date Mfgr Received | 2019-03-08 |
| Date Added to Maude | 2019-04-04 |
| 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 | MTP HEMI-TOE PROSTHESIS |
| Product Code | KWD |
| Date Received | 2019-04-04 |
| 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 | 2019-04-04 |