MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-02-23 for AS INVERSE HUMERAL CUP, OFF CENTER 01.04223.106 manufactured by Zimmer Gmbh.
[15412789]
It was reported that the humeral cup was loosening.
Patient Sequence No: 1, Text Type: D, B5
[15726870]
(b) (4). Conclusion: the quality records indicate that all the specified characteristics (material, measurements, surface, and so on) were in conformity with the requirements in force at the time of mfg. Due to the fact that we are not in possession of any x-rays or surgery documentation we are not able to make a clear statement regarding the mentioned issue. This mdr is being submitted late, as this issue was identified during a retrospective review of complaint files.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2009-00282 |
| MDR Report Key | 1615839 |
| Report Source | 05,08 |
| Date Received | 2010-02-23 |
| Date of Report | 2007-03-12 |
| Date of Event | 2007-03-12 |
| Date Facility Aware | 2007-03-12 |
| Report Date | 2007-03-12 |
| Date Mfgr Received | 2007-03-12 |
| Device Manufacturer Date | 2006-09-28 |
| Date Added to Maude | 2010-03-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DALE MILLER |
| Manufacturer Street | PO BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5742676131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AS INVERSE HUMERAL CUP, OFF CENTER |
| Generic Name | ANATOMICAL SHOULDER INVERSE/REVERSE |
| Product Code | KYM |
| Date Received | 2010-02-23 |
| Returned To Mfg | 2007-03-12 |
| Catalog Number | 01.04223.106 |
| Lot Number | 2345897 |
| Device Expiration Date | 2011-09-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 8 DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-02-23 |