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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VERSA DIAL HEAD; SHOULDER PROSTHESIS/EXTREMITIES

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ZIMMER BIOMET, INC. UNKNOWN VERSA DIAL HEAD; SHOULDER PROSTHESIS/EXTREMITIES Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 11/03/2021
Event Type  Injury  
Event Description
It was reported that the patient underwent shoulder arthroplasty on an unknown date for an unknown reason.Subsequently, the patient was revised due to unknown reasons approximately three (3) weeks ago.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03192.Medical products: item#: 11801, versa-dial/comp ti std taper; lot#: 698330.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product was discarded by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the revision was caused by the patient's rotator cuff being deficient and not caused by a malfunction of the implant.
 
Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03192-1 the following sections were updated: b4; b5; g3; g6; h1; h2 after receiving additional information and reassessment, the item was determined to be not reportable.The tendon tear is unrelated to the implant.The patient was revised due to rotator cuff deficiency.
 
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Brand Name
UNKNOWN VERSA DIAL HEAD
Type of Device
SHOULDER PROSTHESIS/EXTREMITIES
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 Key12869318
MDR Text Key281268087
Report Number0001825034-2021-03193
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/06/2021
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 NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/03/2021
Initial Date FDA Received11/24/2021
Supplement Dates Manufacturer Received11/30/2021
Supplement Dates FDA Received12/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age53 YR
Patient SexFemale
Patient Weight121 KG
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