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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE PLATE 246 MM LENGTH 8 HOLES PROSTHESIS, HIP

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ZIMMER BIOMET, INC. BONE PLATE 246 MM LENGTH 8 HOLES PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swelling (2091)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown cable. Unknown stem. Foreign report source: (b)(6). The device will not be returned for analysis as the device remains implanted; however, an investigation of the reported event is in progress. 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: 0001822565-2020-04168. 0001822565-2020-04169.
 
Event Description
It was reported that approximately 4 days post surgery of a fractured prosthesis, the patient experienced redness and swelling at the wound site. The patient was treated by strengthening dressing change and nutrition treatment. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameBONE PLATE 246 MM LENGTH 8 HOLES
Type of DevicePROSTHESIS, HIP
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 Key11072540
MDR Text Key223714499
Report Number0001822565-2020-04167
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K151716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00223200302
Device Lot Number63853465
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 Received12/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/24/2020 Patient Sequence Number: 1
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