MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-11-19 for TOEMOTION 9M52-2545-W, 9P15-S180-A manufactured by Arthrosurface, Inc..
[31649684]
Patient has ongoing anatomical issues since childhood. She believes that she developed arthritis from injury long ago. Efforts are being made by arthrosurface to understand the issues relative to the implant and the patient. Following up with the patient. A supplemental report will be filed to address all the concerns. Following is the manufacturing information of the patient's components: part # 9m52-2545-w, lot # 75be0409, mfg dt: 02-2015, exp dt: 02-2022. Part # 9p15-s180-a , lot # 75id0436, mfg dt: 09-2014, exp dt: 09-2019. Part # 9095-0018-w, lot # 75jd2821, mfg dt: 11-2014, exp dt: 11-2019. Part # 9p15-pb01-a, lot # 7dd0709 , mfg dt: 04-2014, exp dt: 04-2019.
Patient Sequence No: 1, Text Type: N, H10
[31649745]
Patient had a hemicap mtp implant surgery on (b)(6) 2015 which was revised to a total toe on (b)(6) 2015 due to the excessive pain following surgery. Patient is unsatisfied with current pain level and range of motion.
Patient Sequence No: 1, Text Type: D, B5
[41971415]
Arthrosurface regularly followed-up with the patient to assist with her questions and concerns since the initial complaint. Patient records were obtained and comments from an independent opinion have been forwarded to the patient as her treating physician was on out on medical leave. Patient met and started treatment with a referral physician in her area. The referral physician expressed/ believes that either a scar tissue crowding or a damaged nerve could be causing pain and sensitivity. The patient did get some relief with the initial treatment and will continue treatment with the new physician. The complaint is considered closed at this time. Any additional issues shall be reported as required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004154314-2015-00006 |
| MDR Report Key | 5237389 |
| Report Source | CONSUMER |
| Date Received | 2015-11-19 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-10-21 |
| Date Mfgr Received | 2015-04-21 |
| Date Added to Maude | 2015-11-19 |
| 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 | 2015-11-19 |
| Catalog Number | 9M52-2545-W, 9P15-S180-A |
| Lot Number | 75BE0409, 75ID0436 |
| 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 | 2015-11-19 |