MAUDE Adverse Event Report: Zimmer Orthopaedic Mfg. Ltd. NexGen LPS Femoral Component Size G Right; 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); Loss of Range of Motion (2032)
Date of Event	09/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee manipulation under anesthesia to treat pain and loss of range of motion approximately three (3) months following right knee arthroplasty.No additional information is available.
Additional Manufacturer Narrative
Cmp-1060012 d10: concomitant devices - nexgen lps-flex articular surface size gh 5-6 10mm catalog #: 00596404210 lot #: 62894164, nexgen stemmed nonaugmentable tibial component size 6 catalog #: 00598604702 lot #: 62958618 g2: foreign - event occurred in united kingdom.H6 : component code - proposed code is mechanical (g04) - femur.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: NexGen LPS Femoral Component Size G Right
• Common Device Name: Prosthesis, Knee
• Manufacturer (Section D): Zimmer Orthopaedic Mfg. Ltd.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): Zimmer Orthopaedic Mfg. Ltd.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50412613
• Report Number: 3007963827-2026-00374
• Device Sequence Number: 9107521
• Product Code: NJL
• UDI-Device Identifier: 00889024405448
• UDI-Public: (01)00889024405448(17)250331(10)63016113
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P060037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: Lay User/Patient
• Device Expiration Date: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00599601702
• Device Lot Number: 63016113
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2015
• 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: 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: Male
• Patient Weight: 161 LB