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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; LOWER LEG IMPLANT/TRAUMA

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ZIMMER BIOMET, INC. UNKNOWN SCREW; LOWER LEG IMPLANT/TRAUMA Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 12/19/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4) d10: medical products: item#: 00494500404, 4.5 mm t-plate 4 holes 84 mm length; lot#: unknown item#: unknown, unknown screw; lot#: unknown item#: unknown, unknown screw; lot#: unknown item#: unknown, unknown screw; lot#: unknown item#: unknown, unknown screw; lot#: unknown g2: foreign: italy no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: notes purulent material that reached/contaminated bone graft, removed plate & screws, i&d performed.Images not submitted to mmi for review, as the event is for infection and submitting images would not enhance the investigation process.A definitive root cause cannot be determined.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 that a patient part of a retrospective clinical study underwent an initial left tibial osteotomy approximately eight (8) years and five (5) months ago.Subsequently, the patient developed an infection approximately a month later and underwent a revision surgery to remove all implants from the patient.An external fixator was placed on the patient.
 
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Brand Name
UNKNOWN SCREW
Type of Device
LOWER LEG IMPLANT/TRAUMA
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key19192576
MDR Text Key341157460
Report Number0001822565-2024-01420
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/16/2024
Initial Date FDA Received04/26/2024
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
Patient Sequence Number1
Treatment
SEE H11 NARRATIVE
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age50 YR
Patient SexMale
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