MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Inaccurate Information (4051)

Patient Problem No Patient Involvement (2645)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis as it remains implanted; 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: 0001032347-2019-00525, 0001032347-2019-00526.Medical products: custom made device, part# cp756106, lot# 110360.Custom made device, part# cp756108, lot# 110390.The user facility is foreign; therefore a facility medwatch report will not be available.Report source ¿ (b)(6).

Event Description

It was reported two mandibular components were in mislabeled boxes.The right mandible component was in the left mandible component package, and the left mandible component was in the right mandible component package.No adverse events were reported as a result of the malfunction.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.The warford right mandible (part# cp756106, lot# 110360) and warford left mandible (part# cp756108, lot# 110390) were not returned for investigation and therefore could not be visually evaluated.A photo was provided which showed the two labels, though it could not be verified from the photo that the implants were in the incorrect package.The dhrs for these products were reviewed; no non-conformances were found.There are no indications of manufacturing defects and there are no updates to the risk documents needed.For patient matched tmj implants (cpxxxxxx) in the previous year (from the notification date) this is the only similar complaint of a mislabeling issue.This is a patient matched product and the lot number is unique to this device.There are no additional complaints on this lot.The most likely underlying cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following fields were updated: date of this report, describe event or problem, device availability, date received by manufacturer, type of report, follow up type, device evaluated by manufacturer, method code, results code, conclusions code, and additional narratives/data.

• Brand Name: CUSTOM MADE DEVICE
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9423633
• MDR Text Key: 191983228
• Report Number: 0001032347-2019-00526
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP756106
• Device Lot Number: 110360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE