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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN LINER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 00408801206-femoral stem beaded 12/14 neck taper-61060389. 00801803602-femoral head sterile product do not resterilize 12/14 taper-61123342. 00620205822-shell porous with cluster holes 58 mm-61132723. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01428. 0002648920 - 2020 - 00233. 0001822565 - 2020 - 01429. Reported event was unable to be confirmed. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported the patient is being indicated for a revision surgery 11 years post implantation due to unknown reasons. A revision has not been reported. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN LINER
Type of DevicePROSTHESIS, HIP
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 Key10244371
MDR Text Key197941231
Report Number0001822565-2020-02400
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/01/2020
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 NumberNI

Patient Treatment Data
Date Received: 07/08/2020 Patient Sequence Number: 1
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