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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN GLENOSPHERE; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. UNKNOWN GLENOSPHERE; PROSTHESIS, SHOULDER Back to Search Results
Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Information (3190)
Event Date 02/28/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01007.
 
Event Description
It was reported that a patient underwent shoulder arthroplasty on an unknown date approximately 7 years ago.Subsequently, patient was revised due to the screw and head disengaging.The procedure took approximately 30 minutes longer to remove the screw from the arm.New screw and head were implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1825034, biomet.
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1825034, biomet.
 
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Brand Name
UNKNOWN GLENOSPHERE
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9860074
MDR Text Key184302661
Report Number0001822565-2020-01008
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK CENTRAL SCREW CAT#NI LOT#NI; UNK CENTRAL SCREW CAT#NI LOT#NI
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age33 YR
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