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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW TRAUMA, IMPLANT

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ZIMMER BIOMET, INC. UNKNOWN SCREW TRAUMA, IMPLANT Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection; Noise, Audible
Event Date 03/16/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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

It is reported that 1 patient experienced pain and clicking around the knee after bony union; underwent revision surgery at 2-4 months post-surgery due to distal screw loosening where irritating screw was removed under local anesthesia.

 
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Brand NameUNKNOWN SCREW
Type of DeviceTRAUMA, IMPLANT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key8040487
Report Number0001822565-2018-06164
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 11/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 11/05/2018 Patient Sequence Number: 1
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