MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM L- PLATE-RIGHT - REGULAR; BONE PLATE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Udi #: (b)(4).Medical product: biomet lactosorb l-plate left - regular catalog #: 915-2102 lot #: ni.Biomet 2.0 x 7mm lactosorb screw catalog #: 915-2301 lot #: ni.Therapy date: (b)(6) 2018.Report source: foreign country - (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001032347-2018-00492 and 0001032347-2018-00493.

Event Description

It was reported there was a revision due to osteolysis.No additional patient consequences were reported.

Manufacturer Narrative

There was a revision performed in which the implants were removed, therefore the complaint is considered confirmed.A picture of the explants was provided in which there appears to be a fragment of these implants with adherent tissue, however no conclusion can be reached as to the identity of this fragment or cause of this complaint due to the limited content of the picture.Functional testing and inspections could not be performed due to the parts not being returned.However, osteolysis, or bone resorption was reported to have been observed twice on this patient, and the reason for this revision.Also, the patient's initial surgery (b)(6) 2017 was a le-fort 1 osteotomy which is done to correct facial deformities.This information indicates that the most likely underlying cause of the complaint is patient condition as there was no specific allegation made against the implants.Device history record (dhr) review was unable to be performed as the lot numbers of the devices involved in the event are unknown.The instructions for use (ifu) has the following information for which the product should not be used under the section titled contraindications: patient conditions including, blood supply limitations, insufficient quantity or quality of bone stock or latent infection.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.Device evaluated by manufacturer and not returned to manufacturer.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00492-1 and 0001032347-2018-00493-1.

Event Description

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

• Brand Name: 2.0 LACTOSORB SYSTEM L- PLATE-RIGHT - REGULAR
• Type of Device: BONE PLATE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7761371
• MDR Text Key: 116369485
• Report Number: 0001032347-2018-00494
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK971870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 915-2101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention