MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TIBIAL COMPONENT PRECOAT SIZE 2; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: palacos cement item # 00111314001 lot # 80684396, palacos cement item # 00111314001 lot # 79964393, femoral component item # 00599601452 lot # 62896158, polyethylene insert item # 00597206529 lot # 62989688, art surface item # 00596202212 lot # 62809714.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04775.0001822565-2019-04776.Complaint was unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no related deviations or anomalies.Medical records were not provided.Per the nexgen cr, ps, cra, lps, and lcck package insert, pain and loosening are known potential adverse effects of this procedure.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.
Event or Problem Description
It was reported patient underwent right total knee arthroplasty.Subsequently, patient underwent a revision procedure approximately two years post-implantation due to loosening and pain.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: a1, a4, b4, b5, b7, g3, g6, h2, h6, and h10.
Event or Problem Description
It was reported the patient underwent a right knee revision approximately two years post-implantation due to tibial tray loosening and pain.The tibial tray was removed and replaced with zimmer biomet product.No further complications have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient needed cortisone injections, xrays showed radiolucency around the tibial tray in both knees, patient needed to walk with a cane and had limited ambulation, right total knee has a loosened tibia with and increased report of pain, improvement seen with revision.Root cause was unable to 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TIBIAL COMPONENT PRECOAT SIZE 2
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9787159
• Report Number: 0002648920-2020-00158
• Device Sequence Number: 2289069
• Product Code: JWH
• UDI-Device Identifier: 00889024217560
• UDI-Public: (01)00889024217560(17)250531(10)62685639
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2022

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00598002702
• Device Lot Number: 62685639
• 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: 03/02/2020
• Supplement Date Received by Manufacturer: 08/02/2022; 12/13/2022
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 08/25/2022; 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2015
• 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: Unknown
• 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: Female
• Patient Weight: 112 KG