MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN SCREW; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.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: 0001032347-2020-00626.Concomitant medical products: tmj system right narrow mandibular component 55 mm, part# 01-6555, lot# 747640, tmj system right investigative fossa, large, part# 01-6564, lot# 109331, unknown screws, part# ni, lot# ni.

Event Description

It was reported that the patient will undergo a revision of temporomandibular joint implants on the right side nineteen (19) years following implantation due to a failing screw, periodic pain and swelling.X-rays revealed a radiolucency around the screw that the surgeon interprets as screw failure due to poor bone purchase.The surgeon wishes to replace the implant with a custom device because the patient has a thin arch, but no revision date has been reported at this time.No additional patient consequences have been reported.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Operative notes were not provided.Xrays were provided and reviewed by a healthcare professional.Three views of the right mental on ct demonstrate a plate fixation device of the mandible.There are screws seen within the skull base with possible radiolucency surrounding a screw seen within the temporal bone on the coronal image laterally.Overall fit and alignment of the implants is appropriate.Arch thickness is not well evaluated on these three images.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: UNKNOWN SCREW
• Type of Device: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11065033
• MDR Text Key: 223392502
• Report Number: 0001032347-2020-00625
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2004
• Device Model Number: N/A
• Device Catalogue Number: 01-6555
• Device Lot Number: 747640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention