MAUDE Adverse Event Report: BIOMET MICROFIXATION 55MM LFT STANDARD MAND; PROSTHESIS, MICROFIXATION

Catalog Number 24-6556

Device Problems Flaked (1246); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00291.Implanted: 2005 - exact date unknown.Explanted: 2021 - exact date unknown.Concomitant medical products: item# 24-6550; lot# 851360; item# 24-6560; lot# 934560; item# 24-6563-1; lot# 934590; item# unknown screw; lot# unknown.Report source: foreign - event occurred in (b)(6).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.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 the patient will undergo a revision of bilateral temporomandibular joint implants approximately fifteen (15) years following implantation due to abnormal anatomy and migration of the mandibular component.The stock devices will be replaced with a custom implant.No additional patient consequences have been reported.Attempts have been made and no further information has been provided.

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.The following sections were updated/corrected: b4; b5; d4; d9; g3; g6; h1; h2; h3; h6.D4: udi - (b)(4).The devices were returned for investigation.Visual examination of the returned product confirmed the products identity.The devices showed signs of use with minor scratches and scuffs on the surfaces.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Event Description

It was reported the patient underwent a revision of bilateral temporomandibular joint implants approximately fifteen (15) years post-implantation due to abnormal anatomy.The stock devices will be replaced with a custom implant.Subsequently, it was later reported that while the left stock implant was being removed, the rough finish of the device flaked off and remained in the patient.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The root cause of the previous investigation does not change.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.

Event Description

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

• Brand Name: 55MM LFT STANDARD MAND
• Type of Device: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12319016
• MDR Text Key: 266418450
• Report Number: 0001032347-2021-00392
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 0841036036508
• UDI-Public: (01)0841036036508(17)070301(30)14(10)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 24-6556
• Device Lot Number: 790490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 11/24/2021; 02/10/2022; 06/20/2022
• Supplement Dates FDA Received: 12/07/2021; 02/21/2022; 06/29/2022
• 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
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male