MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW; PLATE, BONE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Headache (1880); Pain (1994); Swelling (2091); Inadequate Pain Relief (2388); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis as it remains implanted in the patient; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00088, 0001032347-2020-00089, 0001032347-2020-00090, 0001032347-2020-00091, 0001032347-2020-00092, 0001032347-2020-00093, 0001032347-2020-00094, 0001032347-2020-00095.Concomitant medical products: tmj system right standard mandibular component, part# 24-6545, lot# 183570; tmj system left standard mandibular component, part# 24-6546, lot# 174120; tmj system right fossa component, small, part# 24-6562, lot# 216350; tmj system left fossa component, small, part# 24-6563, lot# 190720; 2.4mm system high torque (ht) cross-drive screw, part# 91-2708, lot# unk; 2.4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk; tmj system cross drive fossa screw, part# 99-6579, lot# unk; tmj system cross drive fossa screw, part# 99-6581, lot# unk.Initial reporter - patient.

Event Description

It was reported the patient underwent a revision surgery due to heterotopic bone growth and dislocation involving bilateral temporomandibular joint prostheses.The patient was received stock implants over a decade ago, and currently reports limited range of motion, headaches, pain and swelling.Fifteen months ago, the patient reported heterotopic ossification in the joint and implant dislocation on the right side.Thirteen months ago, the patient reported a revision surgery in which the existing implants were re-positioned.Trigger point injections and nerve blocks have been inadequate regarding pain management.No additional patient consequences were reported.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed as a revision surgery was reported to address the bone overgrowth and dislocation.No product was returned; therefore, no functional tests or inspections could be conducted.No scans or physician's reports were provided.The non-conformance database could not be reviewed for the screws involved in this case due to the lot numbers remaining unknown.There are no indications of manufacturing defects.The most likely underlying cause of the bone growth is due to patient condition.It was reported that this bone growth was the cause of the dislocation.It could not be determined from the information provided if the limited range of motion and pain were related to the bone growth and dislocation, or if they were separate issues.The root causes of the reported possible allergic reaction to titanium and infection could not be determined.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.The following fields were updated: b4 date of this report; b5 describe event or problem; d10 device availability; g4 date received by manufacturer; g7 type of report; h2 follow up type; h3 device evaluated by manufacturer; h6 method code; h6 results code; h6 conclusions code; h10 additional narratives/data.

• Brand Name: 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9677229
• MDR Text Key: 177994730
• Report Number: 0001032347-2020-00092
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036053635
• UDI-Public: 00841036053635
• Combination Product (y/n): N
• PMA/PMN Number: K001238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-2708
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2020
• 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; Disability