MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-24 for CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT manufactured by Arthrosurface, Inc..
[75871344]
Arthrosurface has limited knowledge regarding the patient's actual medical background surrounding his toe complications and issues. Patient had multiple surgeries on the first mtp joint in his right foot. Note that the patient's medial sesamoid bone was removed and replaced by a bone tissue transplant. Based on the information provided, the patient apparently had issues prior to the implantation of arthrosurface device. Patient expressed dissatisfaction over hemicap decompression beyond the recommended length and the surgical technique that was carried out. Upon consulting other physicians for a second opinion, patient learned that he has neuropathic (damaged) posterior tibial nerve from earlier surgeries which may be causing pain. There is no discernible evidence that arthrosurface hemicap had actually caused or contributed to any of the reported issues or complications. Several factors including surgical technique, compliance to post-operative rehabilitation techniques, patient selection factors such as age, disease condition etc, contribute to the outcome of the surgery. The patient retains the hemicap device as of the reported date. The lot number of arthrosurface device was not provided without which review of dhr or performance history of the lot in question is not possible. The patient is currently pursuing treatment from an orthopedic physician in his home country. Should arthrosurface receive any additional information regarding this complaint, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[75871345]
On 04/24/2017, the patient emailed his original surgeon, facility staff and arthrosurface regarding his issues/ complications surrounding current & previous implants and related surgeries. The patient obtained treatment in us although being an (b)(6) native. Following are the surgical events related to the patient that were performed by the same surgeon. In (b)(6) 2013, patient received a medial sesamoid transplant (bone tissue supplied by (b)(6)) after having been diagnosed with a damaged sesamoid bone in an injury. Per patient, the transplant failed. This led to pain and other problems in his toe. In (b)(6) 2014 the patient received a hemicap df implant (manufactured by arthrosurface) due to arthritis of the hallux. However, the patient believes that he was never a candidate for hemicap or any other prosthesis procedure. As the patient continued to have pain and could not walk without support, he was re-operated to remove the sesamoid transplant and to reposition the abductor hallucis muscle in (b)(6) 2016. Following the third surgery, the patient returned to (b)(6) and consulted two additional surgeons to address pain and seek further treatment. He learned that his posterior tibial nerve is damaged from a surgery. The patient believes that none of the above stated surgeries helped him restore his original lifestyle. Currently, the patient is concerned about the loss of range of motion, excessive decompression and pain in his operated toe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00005 |
| MDR Report Key | 6588060 |
| Report Source | CONSUMER |
| Date Received | 2017-05-24 |
| Date of Report | 2017-04-24 |
| Date Mfgr Received | 2017-04-24 |
| Date Added to Maude | 2017-05-24 |
| 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) POLYMER PROSTHESIS. |
| Product Code | KWD |
| Date Received | 2017-05-24 |
| 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 | 2017-05-24 |