MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-26 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..
[122036089]
From the radiographs provided by the patient, lucency was noted around the phalangeal implant indicating loosening. The cause for reported issue is unknown. The device is unable to be returned for investigation as it remains implanted in the patient. The device history records of the implant lots in question were reviewed and noted that each lot was built to established specifications. The non-conforming parts were appropriately identified and segregated accordingly. The instructions for use (ifu) document states that this type of event can occur and all risks are addressed in the risk documentation. Several factors such as stress/ physical loads on the implants, vascularity of the implantation site, surgical techniques employed during implantation, patient factors (such as age, current state of the immune system, bone quality, and sensitivity to device materials), and patient post-op compliance to rehabilitation procedures etc. , can have impact on the functional effectiveness of the implanted devices. The implant materials and combinations have decades of history for use in joint replacement applications. Also, the implant materials have been evaluated for biocompatibility to demonstrate safety for intended purposes. Per initial information, the patient is currently planning on a revision to a fusion. The patient has since not responded to follow-up attempts. Should arthrosurface receive any further information regarding this event in future, it will be documented and reported accordingly through a supplemental mdr. Below is the information related to the implanted device. Part # 9p15-pb01-w , lot # 75gf0711, mfg. Date: 08/10/2016, exp. Date: 08/10/2023; part # 9p15-s180-w , lot # 75hf0209, mfg. Date: 08/08/2016 , exp. Date: 08/08/2021.
Patient Sequence No: 1, Text Type: N, H10
[122036090]
An arthrosurface regional manager was contacted by a toemotion patient who is seeking referral surgeon information. It was learned that the patient has lucency around the implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2018-00016 |
| MDR Report Key | 7911839 |
| Date Received | 2018-09-26 |
| Date of Report | 2018-08-26 |
| Date Mfgr Received | 2018-08-26 |
| Date Added to Maude | 2018-09-26 |
| 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 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 | 2018-09-26 |
| 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 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-26 |