MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2013-08-15 for VERSYS PROVISIONAL FEMORAL HEAD 00789503602 manufactured by Zimmer, Inc..
[3832149]
It is reported that the surgeon reduced the joint with a trial head. The surgeon then tried to remove the trial and it was discovered that the head was jammed on the stem trunnion. Upon trying to remove the head, the stem was loosened in the cement mantle because the head gripped the trunnion so strongly. The stem was removed and a new stem was placed. A different trial head also stuck to this stem, but was able to be tapped off.
Patient Sequence No: 1, Text Type: D, B5
[11070777]
This report will be amended when our investigation is compete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2013-01239 |
| MDR Report Key | 3300755 |
| Report Source | 01,05,08 |
| Date Received | 2013-08-15 |
| Date of Report | 2013-07-17 |
| Date of Event | 2013-07-17 |
| Date Mfgr Received | 2013-07-17 |
| Date Added to Maude | 2013-09-04 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P. O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSYS PROVISIONAL FEMORAL HEAD |
| Product Code | HSA |
| Date Received | 2013-08-15 |
| Catalog Number | 00789503602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P. O. BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-15 |