MAUDE Adverse Event Report: BIOMET MICROFIXATION LETHBRIDGE PM-TMJ & MODEL; PROSTHESIS, MICROFIXATION

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was implanted in (b)(6) 2017.Unk screw cat#: n/a lot#: n/a.Report source- (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001032347 - 2021 - 00370.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

It was reported that a patient underwent an initial implantation approximately four years and three months ago.Subsequently, patient is indicated to be revised on an unknown date due experiencing discomfort and dislocation of the joint.Attempts have been made and no further information has been provided.

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 for the tmjpm device identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The design of the device was reviewed by the designer, 3d systems; at the time of shipment for this case, all 3ds models and guides passed final inspection requirements per wi 470-503 tmj-pmi final inspection and shipping.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 is available at the time of report.

• Brand Name: LETHBRIDGE PM-TMJ & MODEL
• Type of Device: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12154499
• MDR Text Key: 261231967
• Report Number: 0001032347-2021-00369
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036225346
• UDI-Public: (01)00841036225346(17)211217(10)731660
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-1623
• Device Lot Number: 731660A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female