MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN 13MM DIA 100MM L STRAIGHT STEM EXT COMBINED 145MM; PROSTHESIS, KNEE

Catalog Number	00598801013
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was revised because there was metal debris.The femur was not secure to the stem extension it was attached to.The hcp deduced the screws used to secure the stem extension to the femur loosened, or were damaged.The femoral and stem were revised for cause.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 00588001402, right size d femoral component, lot# 63277044.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h6: suggested code (annex g)- mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: slight offset at the tibiofemoral arthroplasty articulation and areas of osteolysis as noted.This complaint cannot be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.D10: additional associated products 00588001402 right size d cemented option femoral component lot# 63277044, 00585001296 polyethylene insert xt size b lot# 66866849, 00585002012 articular surface with segmental hinge post size b 12 mm lot# 65244789, 00585204035 stem collar 35 mm o.D.Lot# 66323325, 00585004604 segment with male/female taper 40 mm length lot# 66467268, 00585205014 fluted stem ext st precoat 14 mm dia 130 mm l lot# 66815526, 00585004202 distal femoral xt component size b lot# 66651220.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN 13MM DIA 100MM L STRAIGHT STEM EXT COMBINED 145MM
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21364346
• Report Number: 0002648920-2025-00039
• Device Sequence Number: 8465338
• Product Code: JWH
• UDI-Device Identifier: 00889024220973
• UDI-Public: (01)00889024220973(17)260228(10)63289865
• 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 Explanted Year: 2025
• 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): 07/15/2025

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: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 00598801013
• Device Lot Number: 63289865
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 53 KG