MAUDE Adverse Event Report: BIOMET MICROFIXATION UNK SCREW; CRANIOFACIAL BONE SCREW

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

Patient Problem Osteolysis (2377)

Event Date 01/18/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a revision procedure of a left tmjpm prothesis approximately 2 years and 10 months post implantation due to loosening.Bone damage was noted around the screw holes, which was repaired by a bone graft.The tmjpm prothesis and all screws were removed, and the patient is being considered for a new custom implant.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).D10: bernardo pm-tmj & model cat# tmjpm-2755 lot# 973220a.Unk screw cat# unk lot# unk.Unk screw cat# unk, lot# unk.Unk screw, cat# unk, lot# unk.Unk screw cat# unk, lot# unk.Unk screw cat# unk, lot# unk.Unk screw, cat# unk, lot# unk.G2: canada.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: 0001032347-2023- 00347, 0001032347-2023-00356, 0001032347-2023-00357, 0001032347-2023- 00358, 0001032347-2023-00360, 0001032347-2023-00361, 0001032347-2023 -00362.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10 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 for the screws.A definitive root cause cannot be determined.The designer of this device, 3d systems, was notified of this complaint and an investigation was conducted.The digital planning files were reviewed to ensure that the case was planned properly.The scans for the revision case, tmjpm-4305, were overlaid to determine if the implant was placed properly.The patient anatomy from the initial implantation and 4 years postop were overlaid with the planned position of the left mandible implant.Reviewing the overlaid scans revealed that the patient's anatomy may have changed between the initial implantation and 4 years postop, which resulted in some of the screws losing contact with the bone.This could potentially be the reason for the loosening of the implant screws but cannot be determined as the definitive root cause.The reported event is confirmed, based on the investigation provided by 3ds.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

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

• Brand Name: UNK SCREW
• Type of Device: CRANIOFACIAL BONE 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: 17735789
• MDR Text Key: 323272948
• Report Number: 0001032347-2023-00359
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• 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,Followup
• Report Date: 02/28/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• 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 H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female