MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN 18MM DIAMETER 100MM LENGTH STRAIGHT STEM EXTENSION; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: nexgen 14mm height size c,d with locking screw yellow articular surface, catalog#: 00599403014, lot#: 62938369.Nexgen left size d cemented option femoral component, catalog#: 00599401491, lot#: 63746608.Nexgen stemmed tibial component precoat size 3, catalog#: 00598003701, lot#: 63544274.Nexgen 14mm diameter 100mm length offset stem extension, catalog#: 00598802014, lot#: 63632065.Trabecular metal cone full, catalog#: 00545004801, lot#: 63525256.Prc agmt block dist sz d 5mm, catalog#: 00599003410, lot#: 62963054.Prc agmt block dist sz d 5mm, catalog#: 00599003410, lot#: 62999435 competitor bone cement, catalog#: unk, lot#: unk.G2 foreign source: new zealand.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent a left knee revision approximately six years post-implantation due to femoral pain.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) - stem.Reported event was unable to be confirmed due to limited information received from the customer.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: possible radiolucency at the tibial metal-cement interface and early loosening cannot be excluded.The bone has advanced osteoarthritis.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN 18MM DIAMETER 100MM LENGTH STRAIGHT STEM EXTENSION
• 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: 19159842
• Report Number: 0002648920-2024-00115
• Device Sequence Number: 15287600
• Product Code: JWH
• UDI-Device Identifier: 00889024221024
• UDI-Public: (01)00889024221024(17)260228(10)63282086
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 08/07/2024

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 Expiration Date: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 00598801018
• Device Lot Number: 63282086
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female