MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN DISTAL FEMORAL AUGMENT BLOCK PRECOAT; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure four years post implantation due to infection, bone loss and loosening.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).Medical product: nexgen distal femoral augment block precoat catalog # 00599003620 lot # 63372837.Nexgen stem extension catalog # 00598802013 lot # 63632061.Lcck nexgen femoral component catalog # 00599401692 lot # 63723261.Nexgen stem extension catalog # 00598801114 lot # 63260020.Palacos r + g (1x40) catalog # 66022663 lot # 86604591.Stemmed tibial component precoat a/p wedged for cemented use only size 5 catalog # 00598800500 lot # 63569375r.Articular surface use with lps/lps-flex 51 or 52 suffix femorals size ef 14 mm height.Catalog # 00596204014 lot # 63686791.Palacos r + g (1x40) catalog # 66022663 lot # 85694582.Report source: australia.Multiple mdr reports were filled for this event: 0001822565-2022-01231, 0001822565-2022-01251, 0001822565-2022-01252.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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.

• Brand Name: NEXGEN DISTAL FEMORAL AUGMENT BLOCK PRECOAT
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15300114
• Report Number: 0001822565-2022-02482
• Device Sequence Number: 2407297
• Product Code: JWH
• UDI-Device Identifier: 00889024224193
• UDI-Public: (01)00889024224193(17)270228(10)63608021
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 08/26/2022

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 Model Number: N/A
• Device Catalogue Number: 00599003620
• Device Lot Number: 63608021
• 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: 04/05/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• 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: Required Intervention; Hospitalization
• Patient Sex: Female