MAUDE Adverse Event Report: ZIMMER BIOMET, INC.; PLATE, FIXATION, BONE

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2022

Event Type  Injury  

Event Description

It was reported patient underwent left elbow revision three months post implantation due to migration of a screw and fractured plate.It was noted all components were removed and replaced with a competitor's plate.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.The following sections could not be completed because the part/lot information could be: catalog number - 856135040.Lot number - 313190.Expiration date - jun 17, 2029.Udi- (b)(4).Manufacture date ¿ jun 17, 2019.Or the part/lot information could be: catalog number - 856135028.Lot number ¿ 002740.Expiration date - apr 8, 2032 udi- (b)(4).Manufacture date ¿ apr 8, 2022.Or the part/lot information could be: catalog number - 856135024 lot number - 664870.Expiration date - apr 28, 2031.Udi- (b)(4).Manufacture date ¿ apr 28, 2021.Or the part/lot information could be: catalog number - 856135024 lot number ¿ 373450.Expiration date - apr 3, 2029.Udi- (b)(4).Manufacture date apr 3, 2019.Or the part/lot information could be: catalog number - 856135018 lot number - 299440.Expiration date - jan 9, 2030.Udi- (b)(4).Manufacture date ¿ jan 9, 2020.Or the part/lot information could be: catalog number - 856135016 lot number - 421600.Expiration date - jun 13, 2029.Udi- (b)(4).Manufacture date ¿ jun 13, 2019.Additional associated products & mdr: mdr: 0001825034-2022-02829.Item# 851318203; lot# 990140.Additional associated products: item# 851235024; lot# 436560.Item# 851235026; lot# 988770.Item# 851218000; lot# 593920.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: comminuted transcondylar fracture of the distal left humerus with plate and screw fixation radially.Fractured plate is seen on the image labeled event without dislocation.Withdrawn screw is seen along the distal aspect of the proximal fracture plate fragment with possible loosening of the screw proximal to this.Images labeled event demonstrates some bony callus formation with lucent fracture line still seen.Heavy lifting may have contributed to this complication.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Patient non-compliance was noted as a heavy object was lifted.However, it was also indicated that the screw backed out at some time likely prior to the plate fracture therefore, a definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Associated reports: 0001825034-2022-02829-1.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16036665
• MDR Text Key: 306070542
• Report Number: 0001825034-2022-02830
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization