MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT OPTION SIZE F LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#: 00596009900; taper stem plug lot#: 63641543.Item#: 00598004702 stemmed tibial component lot#: 63645133.Item#: 00597206638; all poly patella standard size 38 mm diameter 9.5 mm.Lot#: 63611769 item#: 00596204010 articular surface lot#: 63724294.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is against hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2021 - 00283, 0002648920 - 2021 - 00282, 0001822565 - 2021 - 02720, 0001822565 - 2021 - 02719.
Event or Problem Description
It was reported that the patient presented in clinic with pain in the left knee (zimmer nexgen lps flex total knee implants).Bone scan showed uptake on the tibia.Surgeon's decision was to remove all implants and re-implant with zimmer lcck revision knee system.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.Device did not cause or contribute to the event.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL COMPONENT OPTION SIZE F LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12505326
• Report Number: 3007963827-2021-00206
• Device Sequence Number: 4986537
• Product Code: JWH
• UDI-Device Identifier: 00889024001138
• UDI-Public: (01)00889024001138(17)260930(10)63486742
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00596401651
• Device Lot Number: 63486742
• 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: 08/26/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 88 KG