MAUDE Adverse Event Report: ZIMMER GMBH WAGN CONE PROSTHESIS 135/14; HIP PROSTHESIS

Catalog Number	01.00561.314
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when it came time to open the final stem, an unexpected problem was encountered: the box was perfectly intact, but opening the sterile package, the stem had punctured the second package.After careful analysis, sterility seemed compromised, and therefore the stem was not used.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4) g2: country report source: italy.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
No further information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4,b5,d2,d9,g1,g3,g6,h1,h2,h3,h6 the cmp was confirmed visual examination of the returned product identified a carton that was returned previously opened at the bottom flap.Bottom of the carton has damage on multiple corners and back panel.Double tyvek sealed cavity was returned with the outer cavity previously opened.Inner cavity was sealed upon return and confirmed a puncture from the stem through the tyvek barrier.During evaluation the inner cavity was opened to further evaluate and found the stem shifted out of the foam retaining piece.No other damage was noted.A review of the device manufacturing records confirmed no abnormalities or deviations.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were not provided.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: WAGN CONE PROSTHESIS 135/14
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23490424
• Report Number: 0009613350-2025-00863
• Device Sequence Number: 14648268
• Product Code: LZO
• UDI-Device Identifier: 00889024480797
• UDI-Public: (01)00889024480797(17)260503(10)3070696
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/14/2026

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 Expiration Date: 05/03/2026
• Device Catalogue Number: 01.00561.314
• Device Lot Number: 3070696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• 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
• Patient Sex: Unknown