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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Headache (1880); Pain (1994); Swelling (2091); Inadequate Pain Relief (2388); Limited Mobility Of The Implanted Joint (2671)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
This follow-up report is being submitted to relay additional information.
Additional 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
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9677229
• Report Number: 0001032347-2020-00092
• Device Sequence Number: 19625335
• Product Code: JEY
• UDI-Device Identifier: 00841036053635
• UDI-Public: 00841036053635
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K001238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability