MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-02-04 for MCP SZ. 30 PROXIMAL WW MCP-100-30P-WW manufactured by Ascension Orthopedics.
[5346895]
It was reported that after placing the implant device in the patient, an x-ray indicated the implant had fractured. The top 25% of the proximal stem fractured. The doctor decided to leave the implant in the patient. Although the device fractured, it was reported the patient was not injured. No revision surgery or medical intervention was required. Additional information received via phone call with dr (b)(6): the procedure performed for this event was a mcp arthroplasty. Dr (b)(6) says he will look into providing studies/study results and surgical and/or post op notes that can assist the investigation. He clarified that he did mean 25% of the tip fractured. He left the implant in. He thinks it will hold. He agreed to inform integra if a revision is needed.
Patient Sequence No: 1, Text Type: D, B5
[12877592]
The device will not be returned since it remains implanted. Based on reported information, integra has initiated an investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2015-00002 |
| MDR Report Key | 4490987 |
| Report Source | 05,07 |
| Date Received | 2015-02-04 |
| Date of Report | 2015-01-09 |
| Date of Event | 2015-01-09 |
| Date Mfgr Received | 2015-01-09 |
| Date Added to Maude | 2015-03-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| 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 | 2015-02-04 |
| Catalog Number | MCP-100-30P-WW |
| Lot Number | 142646T |
| 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 | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-04 |