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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN HEAD PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060)
Event Date 10/07/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical records were provided and reviewed by a health care professional. Review of the available records identified the following: the patient was revised due to failed hip arthroplasty. Patient was experiencing pain and instability. Pre operative images identified eccentric positioning of the right femoral head and osteolysis in zones 1-3 of acetabulum and proximal femoral region. The acetabular liner was worn superiorly. Significant scarring of the capsule was observed. The locking ring, liner, and head were replaced. No other findings related to the event were noted. Part and lot identification are necessary for review of device history records, neither were 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: 0001825034 - 2020 - 03951. 0001825034 - 2020 - 03953. 0001825034 - 2020 - 03954.
 
Event Description
It was reported the patient underwent right total hip arthroplasty. Subsequently, patient underwent a revision procedure approximately 21 years later due to pain, instability, implant wear and osteolysis. The head and liner components were removed and replaced. Cup and stem were retained. No further event information available at the time of this report.
 
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Brand NameUNKNOWN HEAD
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 Key10762646
MDR Text Key213916259
Report Number0001825034-2020-03952
Device Sequence Number1
Product Code KWA
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 distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
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 Received10/19/2020
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 NumberN/A

Patient Treatment Data
Date Received: 10/30/2020 Patient Sequence Number: 1
Treatment
ITEM# NI NAME UNK RNGLOC LOT# NI
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