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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM LOCKING RECONSTRUCTION PLATE STRAIGHT PROSTHESIS SHOULDER

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ZIMMER BIOMET, INC. 3.5 MM LOCKING RECONSTRUCTION PLATE STRAIGHT PROSTHESIS SHOULDER Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 04/02/2021
Event Type  Injury  
Manufacturer Narrative

(b)(4). Medical product: catalog #: 00234702022, cortical bone screw selftapping hex head, lot # 63963923 x 4. Catalog #: 00235901635, 3. 5 mm locking screw 16 mm length, lot # 63985493 x 3. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its not being returned by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the patient underwent an internal fixation of the right clavicle fracture approximately 9 months ago. Postoperative c-arm fluoroscopy showed that the fracture was in good alignment and line, and the internal fixation position was good. About 5 months ago, patient returned to the hospital for examination and found the pain caused by the fractured plate. Then, approximately 4 months ago the patient was re- operated on to remove the fractured plate due to pain. Attempts have been made and there is no further information at this time.

 
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Brand Name3.5 MM LOCKING RECONSTRUCTION PLATE STRAIGHT
Type of DevicePROSTHESIS SHOULDER
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 Key12383985
MDR Text Key268671408
Report Number0001822565-2021-02373
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK060710
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/23/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number47493601013
Device LOT Number64236248
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 Received08/05/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/28/2018
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

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