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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Osteolysis (2377); No Information (3190)
Event Date 06/18/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet as the product location is unknown. The investigation is in process. 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: 0001825034-2020-02981, 0001825034-2020-02982, 0001825034-2020-02984.
 
Event Description
It was reported that patient underwent a hip revision after an unknown amount of time post implantation due to unknown reasons. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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.
 
Manufacturer Narrative
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 NameUNKNOWN STEM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10338672
MDR Text Key200824071
Report Number0001825034-2020-02983
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/29/2020 Patient Sequence Number: 1
Treatment
UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN SCREW; UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN LINER
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