MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for ARTHROSURFACE TOEMOTION 9P15-PB01-A/ 9P15-S180-A manufactured by Arthrosurface, Inc..
[188866559]
The patient had provided copies of x-rays on request, which confirmed loosening of the phalangeal component in the bone. The exact cause of reported lucency is unknown. As a part of the investigation, incoming and final inspection records (dhrs) of the lots in question were reviewed and no discrepancies were noted. All parts were built to specification and non-conforming parts were appropriately identified and dispositioned accordingly. The instructions for use (ifu) document states that this type of event can occur, and all risks are addressed in the risk documentation. A valid root cause cannot be established based on available information. 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 patient was advised to get a full work up done by a surgeon which may help in determination of underlying cause(s) of reported loosening. Another mdr was filed for the patient's first toemotion device (mdr #: 3004154314-2019-00011). If additional relevant information is received, it will be reviewed for reportability and submitted via a supplemental mdr. Below is the part and lot information of the patient's second toemotion implant. Pn: 9p15-s180-a, lot # 75ae3004, mfg. Date: 03-2015, exp. Date: 03-2020. Pn: 9p15-pb01-a, lot # 75ae3014, mfg. Date: 02-2015, exp. Date: 02-2020.
Patient Sequence No: 1, Text Type: N, H10
[188866560]
Arthrosurface was informed of this event by the patient through a blogpost on the website. The patient received bilateral toemotion implants in 2015 six months apart. At 3 years post-op, the treating surgeon recommended silicone implants and bone grafts to the patient after noticing lucency around the phalangeal implants. Patient also reported that an md recommended considering fusion in a recent visit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2019-00012 |
| MDR Report Key | 9131473 |
| Date Received | 2019-09-27 |
| Date of Report | 2019-08-28 |
| Date Mfgr Received | 2019-08-28 |
| Date Added to Maude | 2019-09-27 |
| 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 | 0 |
| Brand Name | ARTHROSURFACE TOEMOTION |
| Generic Name | ARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT |
| Product Code | LZJ |
| Date Received | 2019-09-27 |
| Catalog Number | 9P15-PB01-A/ 9P15-S180-A |
| Lot Number | 75AE3014/ 75AE3004 |
| 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 | 2019-09-27 |