MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-25 for HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT manufactured by Arthrosurface, Inc..
[90283401]
The mtp hemicap device remains implanted in the patient and therefore will not be returned, therefore no product evaluation is conducted. No x-rays, scans, pictures, physician's reports etc. , were provided. Current information is insufficient to permit a valid conclusion about the cause of the reported issues. A review of device history record (dhr) review was not conducted as part and lot number of the devices involved are unknown. However, according to the patient's surgeon, the reported issues may be related to patient condition. The outcome of a surgery depends on several factors such as patient's bone quality, surgical operating technique, compliance to post-operative rehabilitation etc. , if any further information is found which would change or alter any conclusions or information, a supplemental mdr will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[90283402]
The patient reached out to arthrosurface via website to inquire about pain and loss of range of motion she is currently experiencing. She received an arthrosurface mtp hemicap device in (b)(6) 2017 and is undergoing pt per surgeon's recommendation to obtain pain relief from the scar tissue. However, the patient is still having continued pain and concerns about range of motion. During a recent follow-up visit, het treating surgeon told that the pain may be due to the friction between the bones on either side of the joint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00023 |
| MDR Report Key | 6978913 |
| Report Source | CONSUMER |
| Date Received | 2017-10-25 |
| Date of Report | 2017-09-25 |
| Date Mfgr Received | 2017-09-25 |
| Date Added to Maude | 2017-10-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT |
| Generic Name | MTP HEMI-TOE PROSTHESIS |
| Product Code | KWD |
| Date Received | 2017-10-25 |
| 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 | 2017-10-25 |