MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-02-20 for MCP SZ. 20 DISTAL WW MCP-100-20D-WW manufactured by Ascension Orthopedics.
[100418674]
Investigation completed: 02/12/2018. No dhr review can be performed as lot information was not provided. The device involved in the reported incident was not returned. The root cause could not be determined. Linked to 1651501-2018-00011.
Patient Sequence No: 1, Text Type: N, H10
[100418675]
This report is 1 of 2 complaints. It was reported an audible noise in the joint after implantation. After ten days, the patient was fully functional in the joint but with an audible ratcheting sound coming from the joint with the implants. The audible noise never went away, so the physician revised the total joint to a silicone implant. Further information from the customer was requested regarding the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2018-00010 |
| MDR Report Key | 7281954 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-20 |
| Date of Report | 2018-01-30 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2018-04-06 |
| Date Added to Maude | 2018-02-20 |
| 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. 20 DISTAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2018-02-20 |
| Catalog Number | MCP-100-20D-WW |
| Lot Number | 170506T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-02-20 |