MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-03-18 for ASCENSION PIP PIP-200-10P-WW PIP-200-10P manufactured by Ascension Orthopedics, Inc..
[16534951]
The distributor reported that a pt in (b)(6) had a proximal component fractured. An x-ray that was supplied confirmed this observation. When the device was returned an add'l fractured proximal component was returned along with a fractured distal component.
Patient Sequence No: 1, Text Type: D, B5
[16662741]
It is unclear how this proximal pip component is related to this event since the implant that was reported as having a stem fracture (as seen in the x-ray). An evaluation of the returned components was completed. The fracture of this component may be due to mishandling. If add'l info is obtained, a supplement report will be filed as appropriate. Conclusions: head-stem fractures, as observed in the size 20 proximal component, are known to occur as a result of surgically impacting an unsupported head as a result of improper oblique osteotomy preparation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2011-00013 |
| MDR Report Key | 2030564 |
| Report Source | 08 |
| Date Received | 2011-03-18 |
| Date of Report | 2011-03-18 |
| Date of Event | 2011-01-11 |
| Date Mfgr Received | 2011-02-18 |
| Date Added to Maude | 2011-03-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEN THOMA |
| Manufacturer Street | 8700 CAMERON RD. |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal | 78754 |
| Manufacturer Phone | 5128361535 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCENSION PIP |
| Generic Name | FINGER PYROLYTIC CARBON PROTHESIS |
| Product Code | KWF |
| Date Received | 2011-03-18 |
| Returned To Mfg | 2011-02-18 |
| Model Number | PIP-200-10P-WW |
| Catalog Number | PIP-200-10P |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Address | 8700 CAMERON RD. AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-03-18 |