MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling (2091); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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: 0001032347-2021-00013.Concomitant medical products: tmj system left fossa component, small, part# 24-6563, lot# 972390d.Tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 819000a.Unknown screws, part# ni, lot# ni.
Event or Problem Description
It was reported the patient experienced limited opening, pain and infection on the left side eight months following implantation of bilateral temporomandibular joint implants.A course of treatment has yet to be determined and no revision has occurred.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00013, 0001032347-2021-00044, 0001032347-2021-00045, 0001032347-2021-00046, 0001032347-2021-00047, 0001032347-2021-00048, 0001032347-2021-00049, 0001032347-2021-00050, 0001032347-2021-00051, 0001032347-2021-00052, 0001032347-2021-00053, 0001032347-2021-00054, 0001032347-2021-00055.D11 ¿ medical products: tmj system left fossa component, small, part# 24-6563, lot# 972390d; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# ni; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot# ni; tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni; tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# ni; unknown mandible screw, part# ni, lot# ni; unknown mandible screw, part# ni, lot# ni; unknown mandible screw, part# ni, lot# ni; unknown mandible screw, part# ni, lot# ni; unknown fossa screw, part# ni, lot# ni; unknown fossa screw, part# ni, lot# ni; unknown fossa screw, part# ni, lot# ni; unknown fossa screw, part# ni, lot# ni.
Event or Problem Description
It was reported the patient experienced limited opening, pain, discomfort, tightness, swelling and infection on the left side eight (8) months following implantation of bilateral temporomandibular joint implants.No cultures have been taken and no medications or additional treatment have been administered.The patient¿s current condition was described as improved but still experiences discomfort, tightness and swelling.No revision is planned at this time.No additional patient consequences have been reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11140150
• Report Number: 0001032347-2021-00014
• Device Sequence Number: 2947521
• Product Code: LZD
• UDI-Device Identifier: 00841036060329
• UDI-Public: 00841036060329
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2021

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 Expiration Date: 05/10/2023
• Device Model Number: N/A
• Device Catalogue Number: 24-6551
• Device Lot Number: 819000A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/08/2021; 08/04/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/04/2021; 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR