MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN SCREW; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).D10 ¿ medical products item# ni, lot# ni, unknown tmj system fossa comp item# ni, lot# ni, unknown tmj system mandible comp item# ni, lot# ni, unknown screw.G3: foreign: canada the reported event was identified during review of a journal article: advanced mandibular reconstruction with fibular free flap and alloplastic tmj prosthesis with digital planning.Pyne jm, davis cm, kelm r, bussolaro c, dobrovolsky w, seikaly h.Advanced mandibular reconstruction with fibular free flap and alloplastic tmj prosthesis with digital planning.Journal of otolaryngology - head & neck surgery.2023;52(1).Doi:10.1186/s40463-023-00639-4 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2024-00019, 0001032347-2024-00021.

Event Description

A journal article was retrieved from journal of otolaryngology - head & neck surgery that reported a study from university of alberta.This was a prospective case series of adult patients who underwent resection of the mandible with condylectomy and mandibular reconstruction with fff and stock alloplastic tmj prosthesis.The study population had a mean age of 53 years at time of surgery (range: 33-85); (3 males/3 females).Normally stock 45 or 50 mm stock biomet prosthesis was used.The indication for surgery for the 6 study patients included the following: (1) tmj erosion, (2) ameloblastoma, (1) osteoblastoma, (1) osteomyelitis and (1) osteoradionecrosis.Follow-up was conducted at postoperatively with a mean length of follow-up time was 14.38 years (range 4.03¿17.43 years).Two complications occurred, 1 major and 1 minor.It was reported in a journal article that one patient underwent a tmj procedure.The study reported one patient acquired a joint infection requiring iv antibiotic therapy, which subsequently resolved, and the patient remained implanted.Attempts have been made and no further information has been provided.

Event Description

No further event information is 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.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN SCREW
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18567658
• MDR Text Key: 333535855
• Report Number: 0001032347-2024-00020
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization