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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NATURAL NAIL 5.0MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE ROD, FIXATION

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ZIMMER, INC. ZIMMER NATURAL NAIL 5.0MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE ROD, FIXATION Back to Search Results
Catalog Number 47248403050
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Loss of Range of Motion (2032); No Code Available (3191); Malunion of Bone (4529)
Event Date 09/01/2015
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Event Description
It was reported patient underwent initial bilateral femoral im nail insertion performed. Subsequently, the patient underwent exchange of two locking screws on the left side approximately two weeks post implantation after the patient complained of pain at the site which the surgeon attributed to screw length. After complications from nonunion of the femoral fracture, the patient underwent additional surgeries including implantation of a cement spacer on the left side approximately one year post implantation due to delayed fracture healing and nonunion. The im nail was retained with no signs of loosening or complication. Approximately one year later, the im nail was removed due to fracture of the femoral neck screw. A left total hip prosthesis was placed. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event. This report is number 2 of 2 mdrs filed for the same patient (reference 0001822565-2017-00430).
 
Event Description
It is reported that the patient underwent a trauma fixation revision approximately eight months post-implantation due to fracture of the cortical screws.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Concomitant medical product: zimmer natural nail 5. 0mm diameter cortical screw - red fixed angle, cat #: 47248403050, lot #: 62294104. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action(s) is/are required. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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.
 
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Brand NameZIMMER NATURAL NAIL 5.0MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6296837
MDR Text Key256276601
Report Number0001822565-2017-00432
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
PK083497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number47248403050
Device Lot Number62321858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2013
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: 02/02/2017 Patient Sequence Number: 1
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