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

Model Number N/A

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).D10: medical product - zimmer biomet fossa component catalog #: unknown lot #: unknown; zimmer biomet mandible component catalog #: unknown lot #: unknown; zimmer biomet screw catalog #: unknown lot #: unknown.G2: foreign - spain.Gonzalez-perez l-m, montes-carmona j-f, torres-carranza e, infante-cossio p.Total joint replacement for immediate reconstruction following ablative surgery for primary tumors of the temporo-mandibular joint.Journal of personalized medicine.2023; 13(7):1021.Https://doi.Org/10.3390/jpm13071021.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2024-00028, 0001032347-2024-00029, 0001032347-2024-00030 & 0001032347-2024-00031.

Event Description

It was reported thorough a review of a journal article titled total joint replacement for immediate reconstruction following ablative surgery for primary tumors of the temporo-mandibular joint published in the journal of personalized medicine that a study was conducted at the oral and maxillofacial surgery of the virgen del rocio university hospital of seville, spain.The study period was between four and thirteen years ago.The objective of this retrospective study was to investigate the clinical, radiological and histopathological characteristics of patients with primary tmj tumors who were managed with ablative surgery and immediate reconstruction with total joint replacement and to evaluate their surgical outcome and morbidity.The study reviewed 24 joints (18 unilateral and 3 bilateral).The study patients underwent ablation of tmj tumors with the placement of zimmer biomet microfixation tmj replacement system®, jacksonville, fl, usa (22 stock and 2 custom-made prosthetic systems).All procedures replaced the glenoid fossa component and the mandibular condyle.The study population had a mean age of 54 years at time of surgery (range: 29-72 years) (9 males/ 12 females).After tmj replacement, all the patients were followed up for at least 5 years (range: 5¿10 years).Mean pain (vas) and preoperative opening (cm) were 5.9 (range: 4¿8) and 3.5 (range: 2.4¿4.8), respectively.Mean pain (vas) and postoperative opening (cm) measured at 5 years were 1 (range: 0¿4) and 4.2 (range: 3¿5.3), respectively.The study reported one patient underwent removal of tmj prostheses due to malocclusion/instability which was a result of loosening of the implant screws.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H3: device evaluated by manufacturer - other: the device could not be evaluated as no product identification was provided and the product was not returned.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.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.H3 other text : see h10.Narrative.

Event Description

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

• Brand Name: UNKNOWN MANDIBLE COMPONENT
• 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: 18567726
• MDR Text Key: 333536848
• Report Number: 0001032347-2024-00029
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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?: 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: 02/13/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization