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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR; PROSTHESIS, SHOULDER

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BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR; PROSTHESIS, SHOULDER Back to Search Results
Catalog Number 118001
Device Problems Migration or Expulsion of Device (1395); Unstable (1667)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 03/09/2015
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 2 of 4 mdrs filed for the same patient (reference 1825034- 2016-04080/ 05418/ 05419/ 05423).
 
Event Description
Patient underwent a right shoulder arthroplasty and 14 days post-implantation, the patient experienced 1 mm of glenoid radiolucency in zone 8.The patient also reported inadequate range of motion at 3 weeks and pain, instability, and impingement at the six week post-operative appointment.No revision has been reported to date.
 
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Brand Name
VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR
Type of Device
PROSTHESIS, 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 Key6206082
MDR Text Key63316083
Report Number0001825034-2016-05418
Device Sequence Number1
Product Code MBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK060716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Physician
Type of Report Initial
Report Date 12/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date11/30/2014
Device Catalogue Number118001
Device Lot Number453060
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age61 YR
Patient Weight79
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