MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM; 2.7X10MM HIGH TORQUE X-DRIVE SCREW

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Adhesion(s) (1695); No Code Available (3191)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

No x-rays, scans, pictures, or physician's reports were provided.The devices currently remain implanted, therefore, no product evaluation is able to be conducted.The lot number is unknown; therefore, the device history records are unable to be reviewed.The warnings in the package insert state this type of event can occur.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.This is report three of six for the same event; reference reports 0001032347-2017-00654 through 0001032347-2017-00659.

Event Description

The patient reported he has experienced squeaking which is worse in cold weather and popping of the jaw.He followed up with his surgeon who stated a screw is loose; the tmj implants will be removed and replaced in (b)(6).

Manufacturer Narrative

The patient advised the loose screw was determined to be due to his bone hollowing out over time.This is supplemental report three of six for the same event, supplemental reports one through six are reported on mfr #0001032347-2017-00654-1 through 0001032347-2017-00659-1.

Event Description

The patient provided the following additional information: the revision surgery was scheduled to take place on (b)(6) 2017.In addition, he reports there is bone growth around the implant and some of the gum will need to be removed.The patient advised the loose screw was determined to be due to his bone hollowing out over time.He states new implants will be placed during the revision.At this time no confirmation has been received that the revision occurred.

Manufacturer Narrative

This is supplemental report three of six for the same event; reference reports 0001032347-2017-00654-2 through 0001032347-2017-00659-2.

Event Description

The surgeon's office confirmed the revision was performed, the prosthesis was fine, the bone growth around the joint was removed, and the squeaking has stopped.Additional information was requested but has not been received at this time.

Event Description

It was further reported through patient¿s medical records that the patient underwent a revision procedure approximately six (6) years ago due to noise and fibrous adhesions.The surgeon noted during the revision procedure the bone was excised along the posterior aspect of the condylar component which was likely the cause of the squeaking.During the revision, the screws and fossa were removed.The fossa was placed in betadine solution and then reimplanted with new screw holes drilled.Finally, the surgeon removed mandible tori and hyperplastic tissue from the oral cavity.

Manufacturer Narrative

This report is being submitted to update additional information in sections a4, b4, b5, b7, g3, g6, h2, h6, and h10.

Event Description

No further event information is available at the time of this report.

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.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: right side fossa was removed then reimplanted with new screw holes.Bone excised along the posterior aspect of the condylar component which was most likely causing the squeaking.On the left side, attempted to translate the jaw, unable to palpate a good joint space and elected to open.Noted fibrous adhesions, space created between the fossa and disk.Disk was in good position and intact.Jaw could be translated forward.Bilateral mandible incision in oral cavity to remove mandible tori (bony growths on the floor of the mouth, normal occurrence in some people, not related to procedure or components).Maxilla incision to excise hyperplastic tissue (overgrowth of gum tissue, not procedure or component related).A definitive root cause cannot be determined.The reported event is confirmed, based on medical records.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 this report.

• Brand Name: LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
• Type of Device: 2.7X10MM HIGH TORQUE X-DRIVE SCREW
• 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 6791137
• MDR Text Key: 82573562
• Report Number: 0001032347-2017-00656
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK001238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Device Unattended
• Device Model Number: N/A
• Device Catalogue Number: 91-2710
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2024
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 88 KG