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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M2A MODULAR HEAD; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNKNOWN M2A MODULAR HEAD; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); No Information (3190)
Event Date 11/03/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent a revision procedure approximately one year and nine months post implantation due to subluxation.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was revealed that the head is uk design control (biolox) and will be filed under uk mfg number.Therefore, the m2a head was determined to have not contributed to the reported event.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, it was revealed that the head is uk design control (biolox) and will be filed under uk mfg number.Therefore, the m2a head was determined to have not contributed to the reported event.The initial report was forwarded in error and should be voided.
 
Event Description
It was reported that the patient underwent a 4th revision procedure of the left hip approximately one year and nine months post implantation due to subluxation and instability.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
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Brand Name
UNKNOWN M2A MODULAR HEAD
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9599234
MDR Text Key175412004
Report Number0001825034-2020-00302
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup
Report Date 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was the Report Sent to FDA? No
Date Manufacturer Received05/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNK BI-METRIC STEM; UNK TRILOGY LINER
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight100
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