MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-08-23 for HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY manufactured by Arthrosurface, Inc..
[155641859]
Neither the duration of the hemicap implant in the patient nor the reasons behind inadequate pain relief are unknown. The rep contacted revision surgeon to obtain additional information regarding this incident, but the surgeon never responded. The exact cause for reported pain is unknown. The part and lot information of the device in question are unknown. Hence, a review of the device history records (dhr) cannot be conducted. The package insert (pi) of the device states that this type of event can occur and all risks are addressed in the risk documentation. An appropriate root cause was unable to be determined as necessary information to adequately investigate the reported events was not provided. The patient has been revised to a fusion and hemicap device has been explanted. Should arthrosurface receive any additional information which would change or alter any conclusions or information, a supplemental mdr will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[155641860]
It was reported that a hemicap patient was revised due to pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2019-00008 |
| MDR Report Key | 8927304 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-08-23 |
| Date of Report | 2019-07-24 |
| Date Mfgr Received | 2019-07-24 |
| Date Added to Maude | 2019-08-23 |
| 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 | 3 |
| Brand Name | HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY |
| Generic Name | TOE HEMICAP |
| Product Code | KWD |
| Date Received | 2019-08-23 |
| 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 | 2019-08-23 |