MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-06 for MCP SZ. 30 PROXIMAL WW MCP-100-30P-WW manufactured by Ascension Orthopedics.
[101660554]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[101660555]
It was reported that the product was implanted for 7 years and signs of excessive wear was noted during a revision surgery scheduled due to squeaking and poor functionality. No incidents during the revision surgery, the implant was replaced and the surgeon was satisfied with the result.
Patient Sequence No: 1, Text Type: D, B5
[131597123]
The part was returned and underwent failure analysis. Both fracture and abrasive wear damage was evident on articulating surface of implant. Fracture damage suggest multiple events due to demanding hand function or trauma. Wear suggests subluxation or dislocation of prosthesis. However, it is not possible to identify cause of fracture and wear. Based on the information available to date, the root cause for the reported event cannot be determined. Possible causes include trauma. If additional information is received, the investigation will be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2018-00015 |
| MDR Report Key | 7318241 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-06 |
| Date of Report | 2017-12-18 |
| Date Mfgr Received | 2018-03-19 |
| Date Added to Maude | 2018-03-06 |
| 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 | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCP SZ. 30 PROXIMAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2018-03-06 |
| Returned To Mfg | 2018-02-02 |
| Catalog Number | MCP-100-30P-WW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-06 |