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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LAG SCREW 10.5MM X 105MM PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. HFN LAG SCREW 10.5MM X 105MM PROSTHESIS, TRAUMA Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651)
Event Date 12/17/2020
Event Type  Injury  
Manufacturer Narrative
Cmp (b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00014 delano lag screw item #: 814510105 lot #: ug1111305d delano a/r screw item #: 814501090 lot #: dnccm1 foreign - event occurred in (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. 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 revision approximately four (4) months ago post implantation due to non-union of the fracture and fracturing of the nail and lag screw. It was reported approximately three (3) weeks ago patient underwent revision. During procedure, components were removed and replaced.
 
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Brand NameHFN LAG SCREW 10.5MM X 105MM
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 Key11125266
MDR Text Key225342787
Report Number0001825034-2021-00015
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
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 Received01/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814510105
Device Lot NumberUG1111305D
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 Received05/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2017
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: 01/06/2021 Patient Sequence Number: 1
Treatment
SEE NARRATIVE IN H10
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