MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-11-21 for DUROM ACETABULAR COMPONENT UNK manufactured by Zimmer Gmbh.
[18296680]
A product liability claim was raised. It was reported that the patient was implanted an unknown durom us acetabular component on an unknown side on (b)(6) 2007 and revised on (b)(6) 2014 due to pain, sepsis and metallosis.
Patient Sequence No: 1, Text Type: D, B5
[18464653]
The manufacturer did not receive devices, x-rays, or other source documents for review. As no lot numbers were provided for the devices, the device history records could not be reviewed. While a cause for this specific event cannot be ascertained from the information provided, the common clinical presentation and the date of the original implantation suggest that this case is related to the issues for which zimmer implemented a notification in july 2008 as referenced above. Should additional information become available and/or the device(s) be returned for evaluation and an investigation result becomes available, that changes this assessment, an amended medical device report will be submitted. The need for further corrective measures is not indicated at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2014-04127 |
| MDR Report Key | 4283559 |
| Report Source | 00,05 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-02-10 |
| Date Mfgr Received | 2014-08-12 |
| Date Added to Maude | 2014-12-01 |
| 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 | 57426761 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 9613350-07/15/2008-001C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUROM ACETABULAR COMPONENT |
| Generic Name | DUROM ACETABULAR COMPONENT |
| Product Code | KWB |
| Date Received | 2014-11-21 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-11-21 |