MAUDE Adverse Event Report: ZIMMER GMBH WAGNER CONE PROSTHESIS®, 125°, UNCEMENTED, ø 20, TAPER 12/14; HIP PROSTHESIS

Catalog Number	0100561220
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unknown 36/0 trial head, #item unknown, #lot 63698610.Unknown 36/-3.5 trial head, #item unknown, #lot 63594667.Unknown trial stem (x2), #item unknown, #lot unknown.Therapy date: unknown.Attempts have been made to gather all product identification information and no further information has been provided.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 trial heads got stuck on wagner cone trials and real implant.Attempts have been made and all available information has been provided.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
Follow up report: (b)(4).Updated: b4,b5,d2,g1,g3,g6,h1,h2,h6.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations for the wagner stem implant ref.0100561220.A review of the device manufacturing records could not be performed due to missing lot number for the two wagner trial stems.Review of the complaint history found no additional related complaints for item (b)(4) and the reported part and lot combination.A review of the complaint history could not be performed due to missing reference and lot numbers for the two wagner trial stem.Based on the available information, the reported event cannot be confirmed.A definitive root cause could not be determined.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: WAGNER CONE PROSTHESIS®, 125°, UNCEMENTED, ø 20, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21883977
• Report Number: 0009613350-2025-00331
• Device Sequence Number: 20857574
• Product Code: LZO
• UDI-Device Identifier: 00889024485082
• UDI-Public: (01)00889024485082(17)290112(10)3185579
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0100561220
• Device Lot Number: 3185579
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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.
• Patient Sex: Unknown