MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SYSTEM 50 X 50MM X .5MM THICK SHEETING; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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.Implantation date was in summer 2019.Explantation date is planned for (b)(6) 2020 the user facility is foreign; therefore, a facility medwatch report will not be available.Report source (b)(6).
Event or Problem Description
It was reported that a patient will undergo a re-operation.The patient was experiencing enophthalmos and diplopia following an orbital floor fracture and was implanted with an orbital plate.Approximately six months after the operation, the patient's symptoms returned and a re-operation is planned.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed as there is an indication of a revision surgery.Functional testing will not be conducted due to the product not being returned.There will be no dhr review as the lot numbers remain unknown.There are no indications of manufacturing defects.For this part (915-2822) and the previous one year (from the notification date) regarding a revision surgery, there is a complaint rate of 0.36% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause is patient condition.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 or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: LACTOSORB SYSTEM 50 X 50MM X .5MM THICK SHEETING
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9772298
• Report Number: 0001032347-2020-00131
• Device Sequence Number: 2185744
• Product Code: JEY
• UDI-Device Identifier: 00841036195328
• UDI-Public: 00841036195328
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 915-2822
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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