MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN 15MM DIAMETER 100MM LENGTH STRAIGHT STEM EXTENSION; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a left knee replacement approximately twelve months post-implantation due to loosening.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).D10 medical devices: nexgen prc agmt block post sz f 10mm catalog#: 00599003602 lot#: 64068372.Nexgen prc agmt block post sz f 10mm catalog#: 00599003602 lot#: 63149149.Nexgen distal femoral augment block precoat size f 5 mm augment with screw catalog#: 00599003610 lot#: 64746753.Nexgen distal femoral augment block precoat size f 5 mm augment with screw catalog#: 00599003610 lot#: 65323179.Rotating hinge knee left size f cemented option femoral catalog#: 00588001601 lot#: 64862679.Size 4 precoat cemented tibial component catalog#: 00588000400 lot#: 65901693.Trabecular metal tibial cone, medium 31x31mm catalog#: 00545001331 lot#: 64882569.Tibial half block augment tapered precoat size 4 15 mm catalog#: 00598800428 lot#: 63383185.12mm diameter 100mm length straight stem extension catalog#: 00598801012 lot#: 64822355.All-poly patella cemented 38 mm diameter catalog#: 42540200038 lot#: 65885881.Articular surface with segmental hinge post size f 17 mm height catalog#: 00585006017 lot#: 64990221.17mm height size f articular surface with hinge post extension catalog#: 00588006017 lot#: 64495430.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, h10, and h11.Proposed component code: mechanical (g04) stem.Medical records were reviewed but the reported issue was unable to be confirmed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: femoral component not completely seen but no definite loosening clearly visualized.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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.

• Brand Name: NEXGEN 15MM 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: 19645326
• Report Number: 0002648920-2024-00212
• Device Sequence Number: 15391446
• Product Code: JWH
• UDI-Device Identifier: 00889024220997
• UDI-Public: (01)00889024220997(17)300630(10)64796921
• 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: 2023
• 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): 11/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598801015
• Device Lot Number: 64796921
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2020
• 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 H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 74 KG