MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-11-08 for PIP SZ. 10 PROXIMAL PIP-200-10D-WW manufactured by Ascension Orthopedics, Inc..
[4081730]
This report is for the same pt id ((b)(6) and (b)(6) ) this report concerns product id pip-200-10d-ww (pip size 10 proximal). The consumer reported she had a pip replacement in the middle finger of the left hand in 2007 due to rheumatoid arthritis. Within a few months after surgery it became an "inverted blow shaped. " it did not cause any pain at the time so it was not revised. Currently they (the pip implants) have 'slipped' and caused blood vessels to rupture. A different surgeon told the consumer that cement was used by the operating surgeon during the initial surgery. A revision surgery was scheduled for (b)(6) 2013. Additional info and x-rays were requested by integra.
Patient Sequence No: 1, Text Type: D, B5
[11363877]
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 | 1651501-2013-00037 |
| MDR Report Key | 3480721 |
| Report Source | 04,07 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-11-11 |
| Date Mfgr Received | 2013-10-21 |
| Date Added to Maude | 2013-11-22 |
| 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 FINKELSTEIN |
| 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 PROXIMAL |
| Generic Name | PIP |
| Product Code | KWF |
| Date Received | 2013-11-08 |
| Catalog Number | PIP-200-10D-WW |
| Lot Number | 04-1301 |
| 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, INC. |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-08 |