MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-05-18 for PIN/BUSHING REPLACEMENT KIT 32810502501 manufactured by Zimmer, Inc..
[1545728]
Pin was replaced due to wear and because ulna component was not aligned.
Patient Sequence No: 1, Text Type: D, B5
[8630287]
(b) (4): eval summary: parts were in vivo 1. 5+ years and all pieces including poly pieces were steam autoclaved prior to return. No post operative x-ray or any other visual means has been provided to confirm whether locking of the pin occurred in the first place. The complaint states that the component is not aligned. Improperly aligned humeral and ulnar components could cause add'l stress on the pins and bushings. The use of earlier revision kits would not have improved the alignment. The exact cause cannot be determined with certainty. Review of the device history records did not find any deviations or anomalies. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the investigation, the need for corrective action is not indicated. Should add'l substantive info be rec'd, the complaint will be reopened. Zimmer, inc. Considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2010-00358 |
| MDR Report Key | 1694235 |
| Report Source | 05,08 |
| Date Received | 2010-05-18 |
| Date of Report | 2010-03-30 |
| Date of Event | 2010-03-29 |
| Date Mfgr Received | 2010-04-20 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2010-05-24 |
| 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 | 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 | PIN/BUSHING REPLACEMENT KIT |
| Generic Name | EXTREMITY PROSTHESIS |
| Product Code | KWJ |
| Date Received | 2010-05-18 |
| Returned To Mfg | 2010-04-20 |
| Model Number | NA |
| Catalog Number | 32810502501 |
| Lot Number | 60996790 |
| 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 | 1. Required No Informationntervention | 2010-05-18 |