MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN FEMORAL COMPONENT; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical products: nexgen stemmed tibial component catalog # 00598004702 lot # j6694285.Nexgen articular surface catalog # 00599404214 lot # 63188909.Nexgen stem catalog # 00598802011 lot # 64252363.Headed screw 48 mm length catalog # 00579104100 lot # 64644578.Stem extension offset 16mm dia x 100mm length(combined length 145mm) catalog # 00598802016 lot # 62376230.Allen medullary cement plugs 1-20 mm diameter flange/10 mm diameter core store in cool dry place catalog # 00801102020 lot # 64563090.Thin osteotome blade 10mm catalog # 430053 lot # 569493.Allen medullary cement plugs 1-28 mm diameter flange/14 mm diameter core store in cool dry place catalog # 00801102028 lot # 64545194.Stem extension offset 11mm dia x 100mm length(combined length 145mm) catalog # 00598802011 lot # 64252363.Report source: (b)(6).Customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2021-02965 and 0001822565-2021-02967.
Event or Problem Description
It was reported patient underwent a revision procedure three years post implantation due to instability and loosening of the tibial components.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Device was not returned.Visual evaluation of the provided pictures shows signs of being implanted.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.X-ray review indicates there is development of radiolucency at the bone cement interface of the tibial component suggesting early loosening, overall fit and alignment is appropriate, osteopenia.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
No further event information available at the time of this report.

• Brand Name: NEXGEN FEMORAL COMPONENT
• 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: 12672327
• Report Number: 0001822565-2021-02969
• Device Sequence Number: 3696195
• Product Code: JWH
• UDI-Device Identifier: 00889024224858
• UDI-Public: (01)00889024224858(17)280630(10)64003235
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 11/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00599401792
• Device Lot Number: 64003235
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2018
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 115 KG