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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
Device Problems Corroded (1131); Material Erosion (1214)
Patient Problems Host-Tissue Reaction (1297); Ossification (1428); Pain (1994); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)
Event Date 08/23/2018
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 location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # unknown, unknown stem, lot # unknown.Item # unknown, unknown cup, lot # unknown.Item # unknown, unknown liner, lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -00995.
 
Event Description
It was reported the patient underwent right hip revision surgery 2 years post implantation due to pain and elevated metal ion levels.It was indicated during the revision procedure, there was evidence of metallosis and corrosion.The acetabular components were noted to have minimal wear; therefore, they were retained.Further noted, post revision improvement in overall cobalt levels and adls.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.Reported event was unable to be confirmed due to limited information received from 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 is 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.
 
Event Description
No further event information available at the time of this report.
 
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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 Key9860261
MDR Text Key189299759
Report Number0001822565-2020-00996
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 health professional,other
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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