MAUDE Adverse Event Report: BIOMET MICROFIXATION BLACKHALL RIGHT MANDIBLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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: , 0001032347-2020-00597, 0001032347-2020-00598, 0001032347-2020-00599.Medical products: tmj system right standard mandibular component 50mm / 9 hole, part# 24-6550, lot# 851360.Tmj system right fossa component, medium, part# 24-6560-int, lot# 934560.Tmj system left standard mandibular component 55mm / 12 hole, part# 24-6556, lot# 790490.Tmj system left fossa component, small, part# 24-6563-int, lot# 934590.Unknown screws, part# ni, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).
Event or Problem Description
It was reported the patient will undergo a revision and replacement of temporomandibular joint implants on the right side due to displacement.The mandible component is displaced laterally out of the fossa component.The devices will be replaced with a custom implant.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Sterile date - unknown.Manufacturing date - unknown.Product id is being updated to unknown part and lot numbers, as the originally reported product id was incorrect.The investigation is still in process.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
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.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.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d1; d4; d10; g3; g6; h1; h2 d10: left mandible ¿ ref:(b)(4), lot: 576350 right fossa ¿ ref:(b)(4), lot: 576410 left fossa ¿ ref:(b)(4), lot: 576420 2mm x 5mm ¿ ref:(b)(4), lot: 341800 2mm x 7mm ¿ ref: (b)(4) lot: 351400 2mm x 9mm ¿ ref: (b)(4), lot: 646740 x 2 2mm x 9mm ¿ ref: (b)(4) lot: 646740 2.3mm x 5mm ¿ ref: (b)(4), lot: 341790 2.7mm x 6mm ¿ ref: (b)(4), lot: 597280 x 2 2.7mm x 8mm ¿ ref:(b)(4), lot: 351420 x2 2.7mm x 8mm ¿ ref: (b)(4), lot: 351420 x 2 2.7mm x 12mm ¿ ref: (b)(4), lot: 623030 x 2 2.7mm x 12mm ¿ ref: (b)(4).Lot: 444550 x 2 3.2mm x 8mm ¿ ref:(b)(4), lot: 620450 x 2 3.2mm x 10mm ¿ ref:(b)(4), lot: 153630 x 2 3.2mm x 10mm ¿ ref: (b)(4), lot: 474840 x 2 3.2mm x 10mm ¿ ref: (b)(4), lot: 929020 x 2 3.2mm x 10mm ¿ ref: cpsc9950, lot: 690020 x 2 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.

• Brand Name: BLACKHALL RIGHT MANDIBLE
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10944385
• Report Number: 0001032347-2020-00596
• Device Sequence Number: 3210928
• Product Code: LZD
• UDI-Device Identifier: 00841036060343
• UDI-Public: 00841036060343
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2021

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: 07/01/2010
• Device Model Number: N/A
• Device Catalogue Number: CP755192
• Device Lot Number: 576300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 07/27/2021; 08/09/2021; 09/27/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 08/05/2021; 08/18/2021; 09/29/2021
• 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 NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention