MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-12-08 for COONRAD/MORREY TOTAL ELBOW PIN/BUSHING REPLACEMENT KIT SMALL 32810502501 manufactured by Zimmer, Inc..
[1039533]
It is reported that when the surgeon tried to implant the replacement kit, it would not fit. It was reported the elbow was a size small. Another replacement kit was opened, which was implanted successfully.
Patient Sequence No: 1, Text Type: D, B5
[8168629]
Evaluation summary: the complaint does not state whether or not the second kit used was the same item number. No item numbers of the previously implanted stems were provided. X-rays were not returned for evaluation. The complaint indicates that the elbow was small. There are different revision bushing kits for the various combinations of implant stems, as noted in the surgical technique. Based on the information provided, the exact cause can not be determined with certainty. Device history records indicate all components were manufactured and inspected to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2008-00885 |
| MDR Report Key | 1310239 |
| Report Source | 05,08 |
| Date Received | 2008-12-08 |
| Date of Report | 2008-11-03 |
| Date of Event | 2008-10-31 |
| Date Facility Aware | 2008-11-03 |
| Report Date | 2008-11-03 |
| Date Mfgr Received | 2008-11-06 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2009-05-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN FIEDLER |
| 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 | COONRAD/MORREY TOTAL ELBOW PIN/BUSHING REPLACEMENT KIT SMALL |
| Generic Name | EXTREMITY PROSTHESIS |
| Product Code | KWJ |
| Date Received | 2008-12-08 |
| Returned To Mfg | 2008-11-03 |
| Model Number | NA |
| Catalog Number | 32810502501 |
| Lot Number | 60996790 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| 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 | 2008-12-08 |