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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 15X155MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 15X155MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Date 04/25/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog#: 010000665, g7 pps ltd acet shell 56f, lot#: 6883509; catalog#: 20103606, g7 longevity neutral 36mm f, lot#: 64922355; catalog#: 650-0661, delta ceramic fem hd 36/0mm, lot#: 3035179. 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: 0001825034-2021-01510, 0001822565-2021-01365.
 
Event Description
It was reported that the patient underwent a left total hip arthroplasty, subsequently, at three days post op, the patient returned to the emergency department for wound dehiscence. Medical intervention was provided. Resolution of the event is pending. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameECHO POR FMRL LAT NC 15X155MM
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 Key11850233
MDR Text Key251494609
Report Number0001825034-2021-01512
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number192115
Device Lot Number478330
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2021
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: 05/19/2021 Patient Sequence Number: 1
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