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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 42MM PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 42MM PROSTHESIS, TRAUMA Back to Search Results
Catalog Number 814550042
Device Problem Fracture (1260)
Patient Problems Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)
Event Date 12/17/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00014, 0001825034-2021-00015. Concomitant medical devices: item# 814611380; lot# 059310; item# 814510105; lot# ug1111305d; item# 814501090; lot# dnccm1; item# 814550046; lot# unk. Foreign - event occurred in (b)(6). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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 was reported patient underwent an arthroplasty approximately seven (7) months ago. Subsequently, patient was revised four (4) months post-implantation due to non-union of the fracture and fracturing of the nail and lag screw.
 
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Brand NameCORTICAL BONE SCR 5.0MM X 42MM
Type of DevicePROSTHESIS, TRAUMA
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 Key11444546
MDR Text Key238633024
Report Number0001825034-2021-00672
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number814550042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
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? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 03/09/2021 Patient Sequence Number: 1
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