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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING / STANDARD PROSTHESIS, SHOULDER

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BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING / STANDARD PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Defective Component
Event Date 09/17/2013
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 the 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. ¿ medical product - comprehensive locking screw catalog #: 180502 lot #:388400, comprehensive locking screw catalog #: 180500 lot #: 828340, comprehensive reverse central screw catalog #: 115383 lot #: 843190, comprehensive reverse shoulder 9 in steinmann catalog #: 405800 lot #: 904720, comprehensive primary stem 10 mm mini catalog #: 113630 lot #: 114710, comprehensive reverse shoulder glenosphere std 36 mm catalog #: 115310 lot #: 603120, comprehensive reverse fixed locking screw catalog #: 180500 lot #: 172380, comprehensive reverse tray co 44 mm catalog #: 115370 lot #: 460110, comprehensive non-locking screw catalog #: 180507 lot #: 258080, comprehensive reverse central screw catalog #: 115382 lot #: 602710. This is 1 of 2 reports being filed for the same patient (reference 1825034-2017-00114 / 00115). 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 that patient was revised approximately 31 days post-implantation due to alleged failure of device. This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

 
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Brand NameCOMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING / STANDARD
Type of DevicePROSTHESIS, SHOULDER
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key6241023
Report Number0001825034-2017-00114
Device Sequence Number1
Product CodePAO
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 01/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date04/30/2018
Device MODEL NumberN/A
Device Catalogue NumberXL-115363
Device LOT Number202280
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/19/2013
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: 01/11/2017 Patient Sequence Number: 1
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