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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID COMPONENT KEELED 52 MM DIAMETER ARTICULAR SURFACE; PROSTHESIS, SHOULDER/EXTREMITY

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ZIMMER BIOMET, INC. GLENOID COMPONENT KEELED 52 MM DIAMETER ARTICULAR SURFACE; PROSTHESIS, SHOULDER/EXTREMITY Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problem Joint Laxity (4526)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mdr (b)(4), 0001822565-2021-00919.Concomitant medical products: item#: 00430205219, offset modular humeral head 19 mm head height 52 mm spherical head diameter; lot#: unknown.Item#: 47430103100, drill with stop bigliani/flatow the complete shoulder solution: lot#: unknown.Item#: 00430103401, keel sponge single use only; lot#: unknown.Item#: 00430103501, pressurizer sponge; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that patient underwent initial procedure approximately nine (9) years and five (5) months ago.It has been determined that patient will be revised due to shoulder instability due to a deficient subscapularis muscle.It was reported that the cause of the deficient is unknown.
 
Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
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Brand Name
GLENOID COMPONENT KEELED 52 MM DIAMETER ARTICULAR SURFACE
Type of Device
PROSTHESIS, SHOULDER/EXTREMITY
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11615116
MDR Text Key243809287
Report Number0001822565-2021-00921
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K982981
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00430008200
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/12/2021
Initial Date FDA Received04/05/2021
Supplement Dates Manufacturer Received05/14/2021
Supplement Dates FDA Received05/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age52 YR
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