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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PROXIMAL STEM; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN PROXIMAL STEM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Event date was sometime in (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to device location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09985.
 
Event Description
It was reported that during hip surgery, the 2 modular components would not seat fully using a standard torque wrench.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
UNKNOWN PROXIMAL STEM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8021677
MDR Text Key125619077
Report Number0001825034-2018-09984
Device Sequence Number1
Product Code JDG
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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
Initial Date Manufacturer Received 10/04/2018
Initial Date FDA Received10/30/2018
Supplement Dates Manufacturer Received02/01/2019
Supplement Dates FDA Received02/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNKNOWN CUP; UNKNOWN DISTAL STEM; UNKNOWN HEAD; UNKNOWN LINER
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