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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP PROSTHESIS HIP

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ZIMMER BIOMET, INC. UNKNOWN CUP PROSTHESIS HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical devices: unk liner, unk head, unk stem. Medwatch - mw5081307. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-11243, 0001825034-2018-11244 and 0001825034-2018-11245. 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. (b)(4).
 
Event Description
It was reported that the patient is suffering from high metal levels, pain & memory loss approximately 2. 5 years of bilateral revision surgery. No additional information available.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
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.
 
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Brand NameUNKNOWN CUP
Type of DevicePROSTHESIS HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8204260
MDR Text Key131698956
Report Number0001825034-2018-11242
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/31/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1
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