MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-13 for ARTHROSURFACE TOEMOTION 9P15-S180-A & 9P15-PB01-A manufactured by Arthrosurface, Inc..
[95596668]
There was no trauma or injury to the patient according to rep who attended the revision case. Arthrosurface obtained feedback from various surgeons regarding post-op images of the implant. The immediate post-op x-ray with a linear opacity around the implant suggests a technical error placing the tap too deep on both sides of the mtp joint which could result in poor fixation immediately and allows debris to get around the implant. Apart from review of the x-rays, device history records (dhrs) of all implant lots in question were reviewed and noted that all parts were manufactured to specification. Additionally, performance history (number of cases recorded) of the implant lots in question was reviewed and noted that no issues or complaints were reported till date. The patient is currently revised to an implant of another manufacturer and all arthrosurface components have been explanted. Arthrosurface will continue to monitor for similar issues. The manufacturing and expiration dates of the phalangeal components in question are: part # 9p15-s180-a, lot # 75ae3004, mfg. Date: 2015-03, exp. Date: 2020-03. Part # 9p15-pb01-a, lot # 75ae3014, mfg. Date: 2015-02, exp. Date: 2020-02.
Patient Sequence No: 1, Text Type: N, H10
[95596669]
Arthrosurface was notified of a revision case where the patient was revised due to loosening of phalangeal implant and bone loss.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00024 |
| MDR Report Key | 7112663 |
| Date Received | 2017-12-13 |
| Date of Report | 2017-12-07 |
| Date Mfgr Received | 2017-12-07 |
| Date Added to Maude | 2017-12-13 |
| 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 | ARTHROSURFACE TOEMOTION |
| Generic Name | ARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT |
| Product Code | LZJ |
| Date Received | 2017-12-13 |
| Catalog Number | 9P15-S180-A & 9P15-PB01-A |
| Lot Number | 75AE3004 & 75AE3014 |
| 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 | 2017-12-13 |