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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 12X140MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 12X140MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)
Event Date 04/19/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted. Year of birth: (b)(6). Concomitant medical products: item number: 163668, item name: 32 mm mod femoral head, item lot: j6138153; item number: 010000662, item name: g7 acetabular shell, item lot: 6161079; item number: 010000848, item name: g7 neutral e1 liner, item lot: 3606652. Foreign report source: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03857; 0001825034 - 2019 - 03858; 0001825034 - 2019 - 03859. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that patient experienced delayed wound healing approximately nine days post-implantation. Patient required two hip aspirations. No additional intervention was required, reports note that the wound concerns were resolved approximately one month post-implantation. No additional information is available at this time.
 
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Brand NameECHO POR FMRL LAT NC 12X140MM
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 Key8946621
MDR Text Key156020579
Report Number0001825034-2019-03856
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K070274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number192112
Device Lot Number911630
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 Received01/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2018
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: 08/29/2019 Patient Sequence Number: 1
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