MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-11-25 for TOEMOTION 9M52-2535-W/ 9P15-PB01-A manufactured by Arthrosurface, Inc..
[32142058]
Patient is currently not happy with the amount of pain relief she is able to get after the surgery. But, satisfied with the range of motion. The treating surgeon scheduled patient for re-cementing the components. Arthrosurface is following up with the patient and monitoring the progress. A supplemental report will be filed as required to provide updates on patient's condition. Following are the details of components implanted in the patient: part # 9m52-2535-w lot # 75jd2904 mfg dt: 12-2014 exp dt: 12-2021. Part # 9095-0018-w lot # 75be2522 mfg dt: 03-2015 exp dt: 03-2020. Part # 9p15-s180-a lot # 75id0436 mfg dt: 09-2014 exp dt: 09-2019. Part # 9p15-pb01-a lot # 75id0208 mfg dt: 10-2014 exp dt: 10-2019.
Patient Sequence No: 1, Text Type: N, H10
[32142059]
Patient contacted arthrosurface to report pain and other on-going issues associated with the right toe after having implanted with toe motion components. Patient wants to be healthy, not be in constant pain and is looking for any advice that arthrosurface could provide with regard to those issues.
Patient Sequence No: 1, Text Type: D, B5
[33187445]
The patient was revised to a non-arthrosurface toe implant on (b)(6) 2015. The arthrosurface components were removed from the patient and the revision was completed without any issue. It is not known how the implant loosened. Patient has had multiple surgeries before and after several discussions, we learned that patient has a device loosening history. Given patient's device loosening history and early weight bearing, it is possible that implant might have loosened. The complaint is considered closed at this time.
Patient Sequence No: 1, Text Type: N, H10
[35234720]
This supplemental report is being filed as per patient's recent ((b)(6) 2015) email regarding the date of revision surgery. The revision date was corrected to (b)(6) 2015. Work-up for ruling out any infections and metal allergy had been done prior to the revision date. On (b)(6) 2015, patient met surgeon for anesthesia and pre-op check up. No other reportable information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004154314-2015-00007 |
| MDR Report Key | 5250336 |
| Report Source | CONSUMER |
| Date Received | 2015-11-25 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-10-29 |
| Date Mfgr Received | 2015-10-29 |
| Date Added to Maude | 2015-11-25 |
| 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 | PATIENT |
| 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 | ARTHROSURFACE, INC. |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOEMOTION |
| Generic Name | PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED |
| Product Code | LZJ |
| Date Received | 2015-11-25 |
| Catalog Number | 9M52-2535-W/ 9P15-PB01-A |
| Lot Number | 75JD2904/ 75ID0208 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-11-25 |