MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE EHLHARDT PM-TMJ & MODEL; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign country - (b)(6.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a revision due to an infection occurred.The patient had bilateral implants, however only the left side was removed.The right side implants remain implanted and a new custom left joint will be implanted in the coming weeks.No additional patient consequences were reported.

Manufacturer Narrative

These parts were implanted (b)(6) 2016, and the right side implants were removed (b)(6) 2017 due to infection; therefore, the complaint is considered confirmed.Functional testing and inspections could not be performed due to the parts not being returned and no photographs, x-rays, scans, or physician reports being provided.Device history record (dhr) for tmjpm-0918 was reviewed and no discrepancies were found.The sterile certificates were reviewed and there were no anomalies found.Dhr review was unable to be performed for the screws as the lot numbers of the devices involved in the event are unknown.There are no indications of manufacturing defects.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00036-1, 0001032347-2019-00037-1, 0001032347-2019-00038-1, and 0001032347-2019-00039-1.

Event Description

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

Event Description

The following additional information was received: the patient had bilateral implants, however only the right side was removed.The left side implants remain implanted and the right side implants were replaced by an orthopedic cement.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Medical device: biomet microfixation tmj system cross drive fossa screws 2.0 x 7 mm, catalog #: 99-6577, lot #: ni; biomet microfixation tmj system cross drive fossa screw 2.0 x 11 mm, catalog #: 99-6581, lot #: ni; biomet microfixation 2.4 system high torque (ht) cross-drive screw 2.7 x 10, catalog #: 91-2710, lot #: ni; biomet microfixation 2.4 mm system high torque (ht) cross-drive screw 2.7 x 12 mm, catalog #: 91-2712, lot #: ni; unknown 14 mm screws, catalog #: ni, lot #: ni.Therapy date: (b)(6) 2017.Event originally read: it was reported a revision due to an infection occurred.The patient had bilateral implants, however only the left side was removed.The right side implants remain implanted and a new custom left joint will be implanted in the coming weeks.No additional patient consequences were reported.Now it reads: the patient had bilateral implants, however only the right side was removed.The left side implants remain implanted and the right side implants were replaced by an orthopedic cement.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00036, 0001032347-2019-00037, 0001032347-2019-00038, and 0001032347-2019-00039.

• Brand Name: CUSTOM MADE DEVICE EHLHARDT PM-TMJ & MODEL
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7939699
• MDR Text Key: 123052526
• Report Number: 0001032347-2018-00675
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2021
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-0918
• Device Lot Number: 682880A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR