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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM SIZE 10 MLT PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN STEM SIZE 10 MLT PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Metal Related Pathology (4530)
Event Date 02/14/2022
Event Type  Injury  
Event Description
It was reported patient underwent left hip revision approximately 11 years post implantation due to metallosis. During the procedure the head and acetabular liner were removed. Liner was damaged upon removal. There were some signs of discoloration inside the femoral head and on the trunnion of the stem. A new liner and a biolox option head were re implanted. Pt cobalt level was noted as 5. 1. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: 00801804001- femoral head sterile product do not resterilize 12/14 taper-unknown and 00630505840- liner standard 3. 5 mm offset 40 mm i. D. For use with 58 mm o. D. Shell-unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00698. Visual examination of the provided pictures identified slight discoloration on the trunnion of the implanted stem and inside the head. All products were covered in bio-debris, and no further evaluation can be made from the provided pictures. Part and lot identification are necessary for review of device history records; neither were provided for the stem. 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.
 
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Brand NameUNKNOWN STEM SIZE 10 MLT
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 Key13712814
MDR Text Key286882185
Report Number0001822565-2022-00700
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
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
Date Manufacturer Received02/14/2022
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: 03/09/2022 Patient Sequence Number: 1
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