MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-11-08 for AS INVERSE HUMERAL CUP, OFF CENTER +9 0104223196 manufactured by Zimmer Gmbh.
[3045056]
The following was reported: pt is a substance abuser and has never complied to dr's advice regarding braces, etc. Shoulder had dislocated many times. Surgeon thus decided to convert inverse / reverse shoulder to an anatomic hemi shoulder. Moreover it was reported that the surgeon only removed glenoid components to accommodate her pt's request. She was pleases with initial fixation and stability.
Patient Sequence No: 1, Text Type: D, B5
[10299091]
The manufacturer did not yet receive explanted devices, x-rays, or other source documents for review. Where lot numbers were received for explanted devices, the device history records were reviewed and found to be conforming. The cause for this specific clinical event cannot be ascertained from the information provided. However there is no indication for a product failure. Should additional information become available and/or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be filed. The need for corrective measures is not indicated at this time and zimmer (b)(4) considers this case as closed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2012-01050 |
| MDR Report Key | 2837653 |
| Report Source | 01,05 |
| Date Received | 2012-11-08 |
| Date of Report | 2012-10-18 |
| Date of Event | 2012-08-24 |
| Date Mfgr Received | 2012-10-18 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2012-11-20 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AS INVERSE HUMERAL CUP, OFF CENTER +9 |
| Generic Name | ANATOMICAL SHOULDER INVERSE/REVERSE |
| Product Code | KYM |
| Date Received | 2012-11-08 |
| Catalog Number | 0104223196 |
| Lot Number | 2494504 |
| Device Expiration Date | 2013-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZERALLEE 8 WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-11-08 |