MAUDE Adverse Event Report: BIOMET MICROFIXATION L. SORENSEN PM-TMJ & MODEL; CUSTOM MADE DEVICE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown screws, part# ni, lot# ni.Initial reporter ¿ sales representative.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (b)(6).

Event Description

It was reported the patient will undergo a revision of bilateral temporomandibular joint implants four (4) years following implantation due to heterotopic bone growth.The surgeon wishes to replace the devices with new custom implants.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11 concomitant medical products unknown mandible screws, part# ni, lot# ni.Unknown fossa screws, part# ni, lot# ni.This report is being submitted to update additional information in section b5, d4, d11 e1, e2, e3, h2, h6 and h10, and a correction to d6.

Event Description

It was reported the patient is experiencing pain and functional issues four (4) years following implantation of bilateral temporomandibular joint implants due to heterotopic bone growth.The surgeon is considering a revision and replacement with a custom device, but a decision has not yet been made on how to treat the patient.It was reported that no further information is available.

Event Description

It was reported the patient is experiencing pain and functional issues four (4) years following implantation of bilateral temporomandibular joint implants due to heterotopic bone growth.The patient will undergo a revision of the right side implant at a future unspecified date and receive a custom device.It was reported that no further information is available.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

Event Description

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

• Brand Name: L. SORENSEN PM-TMJ & MODEL
• Type of Device: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11095891
• MDR Text Key: 224409436
• Report Number: 0001032347-2020-00637
• 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: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-1560
• Device Lot Number: 718910A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention