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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE 36 MM DIAMETER SHOULDER PROSTHESIS

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ZIMMER BIOMET, INC. GLENOSPHERE 36 MM DIAMETER SHOULDER PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Erosion (1750); Unspecified Infection (1930); Osteolysis (2377)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative
Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. Item number: 00434903811, item name: base plate, lot number: 62562700. Item number: 00434901413, item name: humeral stem, lot number: 62363960. Item number: 00434903600, item name: poly liner, lot number: 62890677. Foreign report source: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03036. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient underwent a shoulder revision surgery approximately 5 years post-implantation due to dissociation, osteolysis and scapular notching. During the revision, signs of an infection were noted upon removal of the glenoid components. All products were removed and replaced with antibiotic cement spacer molds. No additional information is available at this time.
 
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Brand NameGLENOSPHERE 36 MM DIAMETER
Type of DeviceSHOULDER PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
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 Key10451320
MDR Text Key204336534
Report Number0001822565-2020-03035
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K130661
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00434903611
Device Lot Number62868099
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/25/2020 Patient Sequence Number: 1
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