MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LPS FLEX FEMORAL COMPONENT-NITROGEN HARDENED SIZE G LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent left knee revision of the tibial insert approximately five years post-implantation.During the revision, metalosis was noted, as well as femoral loosening and fracture of the femoral implant.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Implant date: unknown date in 2017.Concomitant medical products: lps flex art surf gh7 10 10: catalog#: 00596205010, lot#: 63922132.St prc tib plt size 8: catalog#: 00598005702, lot#: 62811268.Foreign source: (b)(6).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.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to not be reportable as the surgeon clarified this was a revision of competitor product.The initial report was made in error and should be disregarded.
Event or Problem Description
Upon reassessment of the reported event, it was determined to not be reportable as the surgeon clarified this was a revision of competitor product.The initial report was made in error and should be disregarded.

• Brand Name: LPS FLEX FEMORAL COMPONENT-NITROGEN HARDENED SIZE G LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13536847
• Report Number: 0001822565-2022-00455
• Device Sequence Number: 4063441
• Product Code: JWH
• UDI-Device Identifier: 00889024213593
• UDI-Public: (01)00889024213593(17)260731(10)63417093
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K062768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00596801751
• Device Lot Number: 63417093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown