MAUDE Adverse Event Report: ZIMMER GMBH NCB PP PR FEM PLT L21H L401MM; Plate, Fixation, Bone

Catalog Number	0202263121
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow up report updated: b4,b5,d1,d2,d4,d6,d9,g1,g3,g4,g6,h1,h2 d4: attempts have been made to gather all product identification information and no further information has been provided.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.
Event or Problem Description
It was reported that the patient underwent a revision due to loosening approximately 3 months post implantation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.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.
Event or Problem Description
It was reported that the patient underwent a revision due to loosening approximately one year post implantation.Attempts have been made and no further information has been provided.

• Brand Name: NCB PP PR FEM PLT L21H L401MM
• Common Device Name: Plate, Fixation, Bone
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25500782
• Report Number: 0009613350-2026-00311
• Device Sequence Number: 16078663
• Product Code: HRS
• UDI-Device Identifier: 00889024292789
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 0202263121
• Device Lot Number: 2993117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2026
• Supplement Date Received by Manufacturer: 07/07/2026; 08/16/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 07/22/2026; 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown