MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT, 50 MM; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Implant date: original stock prosthesis was placed in 2005 concomitant medical products: biomet microfixation unknown tmj screws, catalog #: ni, lot #: ni.Therapy date: (b)(6) 2019.Foreign country source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was discarded.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: 0001032347-2019-00182 and 0001032347-2019-00183.
Event or Problem Description
It was reported a revision was performed due to heterotopic bone formation.The surgeon removed the right fossa but kept the right mandible in the patient.It was reported the prosthesis were in pristine shape.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of evidence to suggest the revision was performed.It was reported that the reason for the revision was due to heterotopic bone formation.There is nothing to indicate that there was an alleged malfunction of the implants.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to patient condition.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00182-1 and 0001032347-2019-00183-1.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT, 50 MM
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8444979
• Report Number: 0001032347-2019-00181
• Device Sequence Number: 14174879
• Product Code: LZD
• UDI-Device Identifier: 00841036060329
• UDI-Public: 00841036060329
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-6551
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention