MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED PRECOAT TIBIAL COMPONENT SIZE 7; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address pain and suspected aseptic loosening approximately three (3) years post-operatively.However, during the revision, all implants were found to be well-fixed.All devices were removed and replaced.Attempts have been made, however, no additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: nexgen lps-flex porous femoral component size g right, catalog #: 00596201752, lot #: 63978412.Nexgen lps-flex prolong articular surface size gh 12mm, catalog #: 00596205012, lot #: 63955082.Nexgen straight stem extension 15mm x 30mm, catalog #: 00598801215, lot #: 64175202.Nexgen standard all poly patella 35mm, catalog #: 00597206535, lot #: 64224630.Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device is not available due to 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 patient; please see all reports associated with this event: 0001822565-2022-00901, 0001822565-2022-00902, 0002648920-2022-00068, 0002648920-2022-00069.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address pain and suspected aseptic loosening approximately three (3) years post-operatively.However, during the revision, all implants were found to be well-fixed.All devices were removed and replaced.Revision operative notes noted osteopenia and that upon removal of the femoral component, there was bone loss anteriorly.The tibial component was removed with minimal bone loss.Attempts have been made, however, no additional information is available at this time.
Additional Manufacturer Narrative
The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 STEMMED PRECOAT TIBIAL COMPONENT SIZE 7
• 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: 13970710
• Report Number: 0002648920-2022-00067
• Device Sequence Number: 4368188
• Product Code: JWH
• UDI-Device Identifier: 00889024217621
• UDI-Public: (01)00889024217621(17)280331(10)63973597
• 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: 2019
• 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): 06/30/2022

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 Model Number: N/A
• Device Catalogue Number: 00598005701
• Device Lot Number: 63973597
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 06/05/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• 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