MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-01-06 for PIP UNK XXX-PIP manufactured by Ascension Orthopedics.
[16054627]
This is the third report of four concerning the same patient. This report concerns the right hand middle finger - proximal pip pyrocarbon implant. It was reported "during my investigation online, i found that your implants may cause synovitis. I experienced this in my right wrist. Therefore, i contacted the doctor who did this surgery and found out these were also ascension. I had the two implants put in pointing and middle finger in the later part of 2009. I began having some problems and went back to the doctor. He said i needed a tenosynovectomy. This was done immediately. He repaired 5 tendons that were to the point of rupture. I still have numbness in the right side on my hand and continuing soreness in my wrist. These implants are still functioning okay but i'm concerned now about the potential for more tendon problems. I would like to know what research has shown on this and long term effects. " additional information was received on (b)(6) 2013. It was reported the implant was 'pyrocarbon pip. Additional information was requested by integra, no other information was provided. This is the same patient previously referenced in mfg report numbers 1651501-2013-00036 and 1651501-2013-00037.
Patient Sequence No: 1, Text Type: D, B5
[16576282]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2013-00048 |
| MDR Report Key | 3565409 |
| Report Source | 04 |
| Date Received | 2014-01-06 |
| Date of Report | 2013-12-13 |
| Date Mfgr Received | 2013-12-13 |
| Date Added to Maude | 2014-01-10 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DR |
| 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 UNK |
| Generic Name | PIP |
| Product Code | NEG |
| Date Received | 2014-01-06 |
| Catalog Number | XXX-PIP |
| 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 | 1. Required No Informationntervention | 2014-01-06 |