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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 Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); Patient Problem/Medical Problem (2688)
Event Date 09/17/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: unknown-unknown biolox head-unknown; us157856-m2a-magnum pf cup 56odx50id-125120; x180312-bi-metric/x por nc 12x140-637830. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product location unknown.
 
Event Description
It was reported the patient underwent a left hip revision approximately 2 months post implantation due to the patient sustaining a fall for unknown reasons and dislocated. It was confirmed patient experienced a intraprosthetic disassociation of the ceramic head from the poly liner. During the procedure the dual mobility head and liner were exchanged. 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 Key11148456
MDR Text Key226079565
Report Number0001825034-2021-00051
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/10/2021
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 NumberNI

Patient Treatment Data
Date Received: 01/11/2021 Patient Sequence Number: 1
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