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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 Problems Material Erosion (1214); Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 07/25/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Unique identifier (udi) #: n/a.Initial surgery occurred in 2016.Revision surgery indicated for 2018.Concomitant medical products: item number: unknown, item name: unknown cup, lot #: unknown, item number: unknown, item name: unknown neck, lot #: unknown, item number: unknown, item name: unknown liner, lot #: unknown, item number: 00771300700, item name: modular femoral stem, lot #: 60825861.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03909, 0001822565-2018-03921.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient has been indicated for hip revision approximately due to elevated ion levels and dislocation.Attempts have been made and no additional information is available.
 
Event Description
It was reported that patient is suffering from metallosis and elevated ion levels at an unknown amount of time post implantation.No revision surgery has been confirmed to date.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected reported event was unable to be confirmed due to limited information received from the customer device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.This additional information does not change the previous investigation.
 
Event Description
It was reported that a patient underwent hip procedure.Approximately 6 years later patient was revised due to unknown reasons.Approximately 1 year later patient was revised again due to unknown reasons.Subsequently, 2 years later patient was revised due to metallosis and elevated cobalt chrome levels.No further event information available at the time of this report.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).
 
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Brand Name
UNKNOWN HEAD
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7778508
MDR Text Key116951020
Report Number0001822565-2018-03920
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
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 Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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