MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LPS FEMORAL COMPONENT PROVISIONAL SIZE D LEFT; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source - foreign: (b)(6).The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.
Event or Problem Description
It was reported that upon removal of the femoral provisional, the patient's medial condyle fractured.Wires and cables were used to treat the fracture.Attempts have been made, however, no additional information is available at this time.

• Brand Name: NEXGEN LPS FEMORAL COMPONENT PROVISIONAL SIZE D LEFT
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11567718
• Report Number: 0001822565-2021-00829
• Device Sequence Number: 3459558
• Product Code: MBH
• UDI-Device Identifier: 00889024227224
• UDI-Public: (01)00889024227224(10)63440537
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: 00599701401
• Device Lot Number: 63440537
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 03/25/2021
• 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: Other