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

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 ostetomy 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.

• 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 Key: 19192583
• MDR Text Key: 341168213
• Report Number: 0001822565-2024-01423
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• 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 Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 04/26/2024
• 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 Number: 1
• Treatment: SEE H11 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male