MAUDE Adverse Event Report: ZIMMER GMBH NCB CRVD FEM SHAF PLT 10H210MM; IMPLANT, TRAUMA

Catalog Number	0202265010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Cable ready cerclage cable with crimp item# 2232-04-18 lot# 66094364.Cable ready cerclage cable with crimp item# 2232-04-18 lot# 66004570.Cable ready cerclage cable with crimp item# 2232-04-18 lot# 62703650.Cable ready cerclage cable with crimp item# 2232-04-18 lot# 66094364.Cable button for ncb polyaxial locking plate item# 47-2232-060-01 lot# 3149852.Cable button for ncb polyaxial locking plate item# 47-2232-060-01 lot# 3160701.Cable button for ncb polyaxial locking plate item# 47-2232-060-01 lot# 3164734.Cable button for ncb polyaxial locking plate item# 47-2232-060-01 lot# 3155728.G2.Report source: 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 will be submitted.
Event or Problem Description
It was reported that ncb curved plate was used for a peri prosthetic fracture, fracture healed but patient has had pain on that leg.Plate may have moved due to biological changes in the patient's anatomy.Plate was removed and synthetic cables used instead.Diligence is completed and no further information on the reported event has been provided.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11 the reported event could not be confirmed due to lack of product/information.No product was returned or pictures provided; a product evaluation could not be performed.Undated radiographs were provided, therefore it is impossible to connect the reported event with the onset of symptoms.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NCB CRVD FEM SHAF PLT 10H210MM
• Common Device Name: IMPLANT, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22520968
• Report Number: 0009613350-2025-00604
• Device Sequence Number: 21039505
• Product Code: HRS
• UDI-Device Identifier: 00889024484238
• UDI-Public: (01)00889024484238(17)320121(10)3098267
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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 Catalogue Number: 0202265010
• Device Lot Number: 3098267
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male