MAUDE Adverse Event Report: BIOMET MICROFIXATION PATIENT MATCHED TOTAL TEMPOROMANDIBULAR JOINT; PATIENT MATCHED TMJ (LEFT FOSSA AND MANDIBLE)

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.The user facility is foreign; therefore a facility medwatch report will not be available.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.(b)(4).

Event Description

It was reported the patient had a fibula reconstruction including osteosynthesis plate with jaw condyle surgery approximately 1-2 years ago.Shortly after surgery the lower jaw started hanging caused by the missing muscle as stabilizer on the operated side.As a result the condyle has a huge distance to the fossa and the condyle does not stay in the fossa.During the surgery to implant the custom tmj the existing recon plate with add on condyle that was not a zimmer biomet part was removed.It was identified the mandibular bone was not fused and loose at the site to be reduced.The fibula graft that was originally placed detached upon removal of the original plate.The surgeon implanted the custom mandible and fossa implants, however the mandibular head sat too far to the left about 0.5 cm, and could not be pressed into the fossa from the lateral side under strong pressure.All components (fossa and mandibula) were removed again.The implants were tested on the model, the two components on both the templates and the implants were about 1 cm apart from each other.No portable joint and implant position could be found.The operation was terminated.The fossa prosthesis was implanted as a placeholder, however the mandibular bone part was fixed with a recon plate.The surgical planning, reviewing the models, and releasing them to surgery was completed by one surgeon, however this surgeon did not perform the surgery.The surgeon who performed the surgery was not involved in the surgical planning.The surgeon who did the surgical planning will see the patient in three months in order to determine if another attempt at implanting the mandible will be made.

Manufacturer Narrative

Though the product was not returned for evaluation, the product identity was confirmed through the device history records and the design vendor conducted an investigation into the design of this case.They stated, ¿a web meeting was held on october 26th, 2016 with the design team, representatives from zimmer biomet, and one of the doctors involved with the case.It was discovered that the planning surgeon did not perform the actual tmj surgery.It was determined that the doctor performing the surgery was not able to place the mandible into the position according to the case plan, thus the mandible implant had an improper fit in relation to the fossa implant.In addition, the improper fit on the models was due to the skull model being broken at some point at the mandible and it was also sterilized which may have caused warping.Skull models for tmj cases are not to be sterilized.Identical parts were printed and inspected by the design vendor and quality assurance personnel with all parts passing final inspection.The re-printed parts were sent to zimmer biomet for further review as well.It was decided that a new ct scan of the patient with the mandible in the current condition will be taken and the design team will redesign the mandible component.They will set the mandible in the correct position or will receive stone models.¿ the complaint was confirmed as the surgeon did not implant the device.The most likely underlying cause is the planning surgeon did not perform the actual surgery.There are no indications of manufacturing defects.The instructions for use has precautions including, ¿the device is limited to surgeons who are adequately trained in the use of the device through hands-on and educational course work.In all cases sound medical practice is to be followed and the surgeon must select the type of device appropriate for treatment.¿.

Manufacturer Narrative

A follow up report will be sent upon completion of the device evaluation.This is report one of six for the same event.Reports two through six are reported on mfr #0001032347-2017-00158 through 0001032347-2017-00162.

Manufacturer Narrative

(in addition to what was already concluded in 0001032347-2016-00670-1): the product identity was confirmed in the evaluation.There were nine returned screws.Looking at the returned screws it can be seen that they were implanted and then removed.There are no signs of a manufacturing defect on any of the screws.The complaint is on the fit of the mandible and there are no present issues observed with the returned screws.Within the design vendor's complaint investigation report, there are indications that the skull model may have been sterilized which would change the form of the skull model and cause the implant to show the gap reported.The skull model is also fractured where the implant attaches to it.This makes it difficult to correctly position the implant on the broken skull model.The design vendor re-printed the skull model to check the implant fit on the patient anatomy and found that the implant fit the skull model.Since the planning surgeon did not conduct the surgery it is possible that the designed surgical procedure was not followed as laid out by the design vendor and the planning surgeon.The returned implant was reviewed against the product print and no discrepancies were found; the thickness was measured in multiple places with calipers and all measurements taken were within specifications.The manufactured implant matches the re-printed model sent by the design vendor.The surgeon went ahead and plated the bone graft with a reconstruction plate and requested a new tmjpm implant be designed with the patients new anatomy.The current design is no longer usable based on the interference between the implanted reconstruction plate and the tmjpm implant.This is report one of six for the same event.Reports two through six are reported on mfr #0001032347-2017-00158 through 0001032347-2017-00162.

• Brand Name: PATIENT MATCHED TOTAL TEMPOROMANDIBULAR JOINT
• Type of Device: PATIENT MATCHED TMJ (LEFT FOSSA AND 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: 6104251
• MDR Text Key: 59973232
• Report Number: 0001032347-2016-00670
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2021
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-1460
• Device Lot Number: 685410
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2016
• 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): Hospitalization; Other; Required Intervention