MAUDE Adverse Event Report: ZIMMER GMBH NCB®, CORTICAL SCREW, 5.0 MM, 38 MM; IMPLANT, TRAUMA

Model Number	N/A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D4.Product id was provided for two screws however, it is unknown which of the two screws was dislodged.Therefore, the dislodged screw could be any of the following: 0202150038 ¿ ncb cortical screw ¿ 3109018.Udi: (b)(4).Manufacturing date: may 03, 2022.Expiration date: may 03, 2027.0202150038 ¿ ncb cortical screw ¿ 3105058 (2).Udi: (b)(4).Manufacturing date: apr 10, 2022.Expiration date: apr 10, 2027.D10.Ncbâ®, periprosthetic femur plate, distal, right, 12 holes, 278 mm item# 0202264012 lot# 3108787.Ncbâ®, cortical screw, 5.0 mm, 38 mm item# 0202150038, lot# 3105058, qty: 2.G2.Report source: japan.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 operation was performed with ncb pp plate system.The patient underwent a revision surgery approximately 21 months post implantation due to one of the screws placed in the metaphyseal region being dislodged from the bone due to a pseudoarthrosis.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.No product was returned; therefore, no dimensional analysis can be performed.Some pictures were provided.The head of the screws shows signs of wear and possible deformation.However, due to lack of product it is not possible to determine the extent to which the combined wear on the screw head and screw hole contributed to the dissociation situation that ultimately led to the revision surgery.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.The imaging of the right femur shows lateral plate and screw fixation involving the mid and distal diaphysis, extending into the lateral femoral condyle.There is an oblique fracture in the distal diaphysis with possible loosening of the fifth and sixth distal screws, dislodgment of the second screw, and partial withdrawal of the first screw.The overall fit and alignment are appropriate in the second image, but the first image indicates loosening of the hardware.Signs of issues include the dislodged second screw, potential loosening of the fifth and sixth screws, and partial withdrawal of the first screw.The bone shows partial healing of the oblique fracture, with a loosened fracture line still visible distally and medially.No other anatomical factors are evident that would contribute to the need for revision.Based on the available information, the reported event can be confirmed.However, a definitive root cause cannot be established.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: NCB®, CORTICAL SCREW, 5.0 MM, 38 MM
• Common Device Name: IMPLANT, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20174140
• Report Number: 0009613350-2024-00441
• Device Sequence Number: 8032511
• Product Code: HRS
• UDI-Device Identifier: 00889024291010
• UDI-Public: (01)00889024291010(17)270503(10)3109018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/16/2025

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 Model Number: N/A
• Device Catalogue Number: 0202150038
• Device Lot Number: 3109018
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown