MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-04-15 for ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE 00434903611 manufactured by Zimmer, Inc..
[20929232]
It is reported that pt underwent total shoulder replacement surgery. Approx 2 weeks post-op, the pt had a dissociation of the glenoid sphere from the glenoid component, approx 23 days later, revision surgery occurred. Exact implant and explant dates are not known.
Patient Sequence No: 1, Text Type: D, B5
[21195168]
Eval summary: it is not known whether or not the device was properly seated during the initial surgery. Straight-on exposure of the glenoid is necessary for both proper reaming and component insertion. The use of base plate reamer 2 (36mm or 40mm) is needed to remove bone around the base plate to avoid impingement with the glenosphere. The probable cause appears to be an intra-operative error during placement of the glenosphere. An exact cause cannot be determined with certainty. Eval: no product or x-rays were returned. 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 additional substantive info be received, the complaint will be reopened. Zimmer considers the investigation closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2008-00177 |
| MDR Report Key | 1033389 |
| Report Source | 06 |
| Date Received | 2008-04-15 |
| Date of Report | 2008-03-04 |
| Date Mfgr Received | 2008-03-17 |
| Date Added to Maude | 2008-04-28 |
| 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 | 0 |
| Manufacturer Contact | ANN RECKTENWALL |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5743718028 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE |
| Generic Name | SHOULDER PROSTHESIS |
| Product Code | KYM |
| Date Received | 2008-04-15 |
| Model Number | NA |
| Catalog Number | 00434903611 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 980307 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-04-15 |