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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN LINER PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Non-union Bone Fracture (2369); Joint Dislocation (2374)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source foreign: (b)(6). Report source: shane p. Russell, cathleen j. O'neill, eoin j. Fahey, shane guerin, rehan gul, james a. Harty. Trabecular metal augments for severe acetabular defects in revision hip arthroplasty: a long-term follow-up(https://doi. Org/10. 1016/j. Arth. 2020. 12. 033). No product was returned or pictures provided; visual and dimensional evaluations could not be performed. Part and lot identification are necessary for review of device history records, neither were provided. Medical records were not provided. A definitive root cause cannot be determined. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00955.
 
Event Description
It was reported in a journal article a patient had recurrent dislocations because of a trochanteric nonunion but has not been revised to date because of medical comorbidities. No further event information available at the time of this report.
 
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Brand NameUNKNOWN LINER
Type of DevicePROSTHETIC, 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 Key11608067
MDR Text Key245822023
Report Number0001822565-2021-00956
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
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 Received03/25/2021
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 Treatment Data
Date Received: 04/02/2021 Patient Sequence Number: 1
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