MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM STRAIGHT PLATE 4 HOLE; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 10/23/2019

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; 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: 0001032347-2019-00583, 0001032347-2019-00584.Concomitant medical products: 1.5 lactosorb system x-plate regular, part# 915-2422, lot# 131070; 2.0 lactosorb system curved plate 6 hole, part# 915-2103, lot# 633300; 2.0 lactosorb system straight plate 4 hole, part# 915-2110, lot# 050460.The user facility is foreign; therefore a facility medwatch report will not be available.Report source ¿ (b)(6).

Event Description

It was reported the patient experienced redness ten months post-operatively following the implantation of absorbable plates in the lower zygomatic area.A revision surgery was performed but the plates were absorbed so the implants could not be removed.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.The str plt 4hle 2.0 lactosorb sys (part# 915-2110, lot# 050460) was not returned for investigation as it was already absorbed and could not be removed.There was no information regarding cultures or allergies.The dhrs for these implants were reviewed; no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint regarding an allergic reaction, infection, or inflammation for this part# 915-2110, lot# 050460.For this part (915-2110) and the previous one year (from the notification date) regarding an allergic reaction, infection, or inflammation, there is a complaint rate of 0.20% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint 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.

Event Description

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

• Brand Name: 2.0 LACTOSORB SYSTEM STRAIGHT PLATE 4 HOLE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9525265
• MDR Text Key: 173305386
• Report Number: 0001032347-2019-00585
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036054557
• UDI-Public: 00841036054557
• Combination Product (y/n): N
• PMA/PMN Number: K955729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2023
• Device Model Number: N/A
• Device Catalogue Number: 915-2110
• Device Lot Number: 050460
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• 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