MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-11-29 for PIP SZ. 40 PROXIMAL PIP-200-40P-WW manufactured by Ascension Orthopedics.
[2539736]
The reporter stated a revision surgery was performed. The surgeon had to replace the index and middle finger with a larger size implant. The joint was loose. All other implants are fine. The surgeon was satisfied with the post operative x-ray.
Patient Sequence No: 1, Text Type: D, B5
[9711280]
The device involved in the reported incident is not expected to be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2011-00093 |
| MDR Report Key | 2453666 |
| Report Source | 08 |
| Date Received | 2011-11-29 |
| Date of Report | 2011-11-29 |
| Date of Event | 2011-01-04 |
| Date Mfgr Received | 2011-11-09 |
| Date Added to Maude | 2012-02-17 |
| 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 D'AGOSTINO |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIP SZ. 40 PROXIMAL |
| Generic Name | PIP |
| Product Code | KWF |
| Date Received | 2011-11-29 |
| Catalog Number | PIP-200-40P-WW |
| Lot Number | 11-1903 REVISED PRODUCT |
| 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 | 1. Required No Informationntervention | 2011-11-29 |