MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-06-01 for PIP SZ. 10 DISTAL PIP-200-10D-WW manufactured by Ascension Orthopedics.
[2675527]
The reporter stated, "her finger was crooked 3 months after proximal interphalangeal (pip) left ring finger joint replacement. The prosthesis bulges out very far on the side next to the index finger. She cannot flex the distal joint on the finger. The finger remains very stiff after weeks of hand therapy, and finger deviates about 15 degrees from middle finger. The pip clicks when bent, and she cannot bend distal joint on said finger at will; can only force distal joint to flex slightly using other hand. The distal joint had no problem before surgery. "
Patient Sequence No: 1, Text Type: D, B5
[9938601]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2012-00030 |
| MDR Report Key | 2612593 |
| Report Source | 04 |
| Date Received | 2012-06-01 |
| Date of Report | 2012-06-01 |
| Date of Event | 2012-05-09 |
| Date Mfgr Received | 2012-05-09 |
| Date Added to Maude | 2012-06-13 |
| 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 | CAREN FERNANDEZ |
| Manufacturer Street | 315 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 | PIP SZ. 10 DISTAL |
| Generic Name | PIP |
| Product Code | KWF |
| Date Received | 2012-06-01 |
| Catalog Number | PIP-200-10D-WW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-06-01 |