MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN SCREW

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Adhesion(s) (1695); Inflammation (1932); Pain (1994); Scar Tissue (2060); Bruxism (4427); Metal Related Pathology (4530)

Event Date 09/22/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).This follow-up report is being submitted to relay additional information.Medical products: item #tmjpm-2218, lot #855940a; pm-tmj & model.Foreign source: south africa.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided for the screw.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial surgery took place and left side was later revised.Contributing factors of the event include bruxism.No op record was provided and lymphocyte proliferation test was negative to titanium iv dioxide lpt melisa and titanium iv oxysulphate lpt.Ct report showed diffuse sclerosis of the residual left mandibular neck and ramus, adjacent to the prosthesis.Screws loose to left mandibular component, gap between mandibular plate and bone, no periprosthetic fracture.The patient presented with discomfort of left ramus prosthesis.Ct found screw fixation devices are all loose and associated with bone loss.Pathology report showed clinical history including severe metallosis in lymph node and pain.Left periparotid lymph node, hyperplasia with foreign pigment, no infection.Synovial tissue and soft tissue surrounding prosthesis showed extensive amount of foreign black material present with foreign body giant cell reaction (metallosis), mild chronic inflammatory cell infiltrate with prominent fibrosis.A definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00334.

Event Description

It was reported the patient underwent a bilateral tmj procedure, and subsequently, the patient has been revised due to infection, inflammation and implant loosening on one side.During the revision procedure, the surgeon found severely discolored (black) soft tissue surrounding the implant and a completely loose implant.The contralateral side seems to be fine and was not opened up.It was further reported that the patient had a bilateral total mandibular joint replacement.Subsequently, the patient has the first stage left revision due to metallosis, pain, loosening, bone loss, inflammation, and scar tissue/adhesions.All components were removed with prp plasma for bone regeneration and elastics implanted for occlusion.

• Brand Name: UNKNOWN SCREW
• Type of Device: SCREW
• 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: 16492713
• MDR Text Key: 310769736
• Report Number: 0001032347-2023-00066
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White