MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-08-25 for HARRIS GALANTE ACETABULAR CUP PUSHER 00902703704 manufactured by Zimmer Inc.
[15221293]
It is reported that while inserting the head, the threads of the cup pusher broke off inside the head.
Patient Sequence No: 1, Text Type: D, B5
[15729087]
Evaluation summary: it is likely that this fracture was caused by off-axis impaction of the cup pusher with the positioner head attached. This would cause an excessive bending moment at the tip and lead to this type of fracture. It is also possible that the impaction forces exceeded the material strength of the cup pusher or that excessive torsional loading was applied. Based on the info provided, a definitive cause for failure cannot be determined with certainty. As returned, the thread tip of the cup pusher has fractured off and remains within the 32 mm positioner head. Device history records indicate all components were manufactured and inspected to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2010-00608 |
| MDR Report Key | 1829413 |
| Report Source | 05,08 |
| Date Received | 2010-08-25 |
| Date of Report | 2010-07-22 |
| Date of Event | 2010-07-19 |
| Date Mfgr Received | 2010-07-28 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2010-11-09 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARRIS GALANTE ACETABULAR CUP PUSHER |
| Generic Name | HIP INSTRUMENT |
| Product Code | HXO |
| Date Received | 2010-08-25 |
| Returned To Mfg | 2010-07-28 |
| Model Number | NA |
| Catalog Number | 00902703704 |
| Lot Number | 60439104 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-08-25 |