MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-02 for HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT manufactured by Arthrosurface, Inc..
[101698551]
The exact cause for reported loosening of the hemicap? Device is unknown. The part and lot information of the device in question were not provided. Hence, a review of the device history record (dhr) cannot be conducted. Also, the duration of the hemicap? Device in the patient is unknown. The package insert of the device states that this type of event(s) can occur and all risks are addressed in the risk documentation. An appropriate root cause was unable to be determined as device components in question were not returned and necessary information to adequately investigate the reported event was not provided. The patient was revised to a different implant from another manufacturer and arthrosurface to emotion components have been explanted. Should arthrosurface receive any additional information which would change or alter any conclusions or information, a supplemental mdr will be filed accordingly. We will continue to monitor the trends.
Patient Sequence No: 1, Text Type: N, H10
[101698552]
Arthrosurface was notified by their eu distributor regarding a revision case where loosening was observed in a hemicap? Mtp patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2018-00004 |
| MDR Report Key | 7311211 |
| Date Received | 2018-03-02 |
| Date of Report | 2018-02-02 |
| Date Mfgr Received | 2018-02-02 |
| Date Added to Maude | 2018-03-02 |
| 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 | 0 |
| Brand Name | HEMICAP? MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT |
| Generic Name | MTP HEMI-TOE PROSTHESIS |
| Product Code | KWD |
| Date Received | 2018-03-02 |
| 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 | 2018-03-02 |