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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVS HMRL TI TRAY 44MM PROSTHESIS, SHOULDER

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BIOMET ORTHOPEDICS COMP RVS HMRL TI TRAY 44MM PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component; Fracture
Event Date 02/03/2016
Event Type  Injury  
Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, "dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and fibrous tissue laxity or excessive activity can also contribute to these conditions. " number 10 state, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight. Number 12 states, "wear and/or deformation of articulating surfaces. " this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

 
Event Description

Patient's legal counsel reported patient underwent right shoulder reverse revision approximately 6 years post-implantation due to alleged pain and the fracture of the humeral tray taper resulting in disassociation of the humeral tray from the stem. All humeral components were removed and replaced. This report is based on allegations set forth in the plaintiff's complaint and the allegations contained therein are unverified. Operative notes revealed that the humeral tray taper had sheared off and remained engaged in the humeral stem and was cold-welded.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of medical records. Device history record was reviewed and no discrepancies were found. Root cause was associated with the design of the device. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
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Brand NameCOMP RVS HMRL TI TRAY 44MM
Type of DevicePROSTHESIS, SHOULDER
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key5949555
Report Number0001825034-2016-03614
Device Sequence Number1
Product CodePAO
Report Source Manufacturer
Source Type OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 01/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number115340
Device LOT Number697120
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/15/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 09/14/2016 Patient Sequence Number: 1
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