TRABECULAR METAL REVERSE SHOULDER, GLENOSPHERE 36 MM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-04 for TRABECULAR METAL REVERSE SHOULDER, GLENOSPHERE 36 MM * manufactured by Zimmer Orthopaedic Surgical Products.

Event Text Entries

[837192] Patient had original surgery, right reverse total shoulder replacement, recently. The patient's status, post reverse total shoulder arthroplasty, when he came back two weeks postop it was noted they had a disassociation of their glenoid sphere from the glenoid component. The patient was recommended for a revision. Brought back for the revision 23 days later. Doctor replaced the zimmer part #00-4349-036-11, trabecular metal reverse shoulder system glenosphere 36mm, and the zimmer part # 00-4349-065-06, trabecular metal reverse shoulder system retentive poly liner 36mm x65 degree. Doctor is interested in having these pieces examined by the zimmer engineers.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number1013006
MDR Report Key1013006
Date Received2008-03-04
Date of Report2008-03-04
Date of Event2008-01-30
Report Date2008-03-04
Date Reported to FDA2008-03-04
Date Added to Maude2008-03-17
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameTRABECULAR METAL REVERSE SHOULDER, GLENOSPHERE 36 MM
Generic NameSYSTEM, TRABECULAR REVERSE SHOULDER
Product CodeKYM
Date Received2008-03-04
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Age1 MO
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key980307
ManufacturerZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
Manufacturer Address200 WEST OHIO AVENUE DOVER OH 44622 US

Device Sequence Number: 2

Brand NameTRABECULAR METAL REVERSE SHOULDER, RETENTIVE POLY LINER 36 M
Generic NameSYSTEM, TRABECULAR REVERSE SHOULDER, POLY LINER
Product CodeKYM
Date Received2008-03-04
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Age1 MO
Implant FlagY
Date RemovedV
Device Sequence No2
Device Event Key980308
ManufacturerZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
Manufacturer Address200 WEST OHIO AVENUE DOVER OH 44622 US

Patients

Patient NumberTreatmentOutcomeDate
10 2008-03-04
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