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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problem Pain (1994)
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.Concomitant medical products: item number: unknown, item name: unknown cup, lot #: unknown.Item number: unknown, item name: unknown head, lot #: unknown.Item number: unknown, item name: unknown liner, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03639, 0001825034-2019-03640, 0001825034-2019-03644.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient underwent an initial hip arthroplasty approximately 4 years ago.Subsequently, patient is experiencing pain and instability.Attempts have been made and no additional information is available at this time.
 
Event Description
No further event information available at the time of this report.
 
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 the customer.Device history record 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 and/or corrected information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It has been further reported that the patient fell causing torn muscles in the right leg along with a possible stress fracture.
 
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Brand Name
UNKNOWN LINER
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8920440
MDR Text Key155189084
Report Number0001825034-2019-03643
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Weight75
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