MAUDE Adverse Event Report: BIOMET MICROFIXATION WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM; JOINT, TEMPOROMANDIBULAR, IMPLANT; LEFT MANDIBLE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); No Information (3190)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis at this time as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitant medical product - zimmer biomet unknown mandible screws catalog #: ni lot #: ni, zimmer biomet unknown left fossa catalog #: ni lot #: ni, zimmer biomet unknown fossa screws catalog #: ni lot #: ni, (b)(6).

Event Description

It was reported the mandibular implant needs to be replaced since 2-3 screws loosened due to the bad bone quality.The surgeon requested a patient matched mandibular implant that is longer towards the chin area to add more holes to fixate everything, as the old screw holes cannot be used again.The revision surgery is not scheduled at this time as this case is still in the design phase.The surgeon originally indicated the stock fossa in place still fit perfectly fine, therefore the surgeon wanted to keep it and just replace the stock mandibular with a patient matched prosthesis.The surgeon believed that a replacement of the fossa component would result in a bad fit due to the bad bone condition and new holes which would be required and make the bone even thinner.There was a web meeting with the surgeon and the design vendor.After the web meeting, the preliminary design indicates a fossa and a mandible implant are being manufactured for the patient.No additional patient consequences were reported.It was reported that multiple devices were used during the procedure and may have caused or contributed to the adverse event.Zimmer biomet requested additional information on these devices from the customer; however, a response has not yet been received.If this information becomes available, a supplemental mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(6) 1994: pain, follow-up type, and additional narratives/data.

Event Description

The sales representative provided additional information regarding the patient status.He stated the patient has pain and feels the loosened screws.There are currently no problems with movement of the jaw.The sales associate is attempting to obtain the product information, he states the original surgery was in 2012.

Manufacturer Narrative

This report is being submitted to relay additional information.There was a revision performed to remove and replace these implants; therefore the complaint is considered confirmed.The surgeon indicated poor bone quality was a contributing condition.Device history record (dhr) review was unable to be performed as the part numbers and lot numbers of the devices 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported the fossa and mandible components were removed and replaced with custom implants on (b)(6) 2018.The surgery was successful, the prosthesis fit perfectly and the surgeon and patient are very happy.

• Brand Name: WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT; LEFT MANDIBLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 7082613
• MDR Text Key: 93718924
• Report Number: 0001032347-2017-00839
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 12/07/2017; 04/26/2018
• Supplement Dates FDA Received: 01/02/2018; 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR