MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC OFFSET STEM 5; PROSTHESIS, HIP

Catalog Number	0100121050
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the stem was reinserted, and it sank, so the surgeon decided to use a stem that was one size larger.There was a 5 to 10 minute delay in the surgery to replace the product.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2: report source japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11.The product was returned for investigation, but it is overall inconspicuous.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.A review of the device manufacturing records confirmed no abnormalities or deviations; therefore is it not expected that a manufacturing issue led or contributed to the reported event.However, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a definitive root cause could not be identified.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ALLOCLASSIC OFFSET STEM 5
• Common Device Name: PROSTHESIS, HIP
• 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: 22292577
• Report Number: 0009613350-2025-00448
• Device Sequence Number: 21055923
• Product Code: LZO
• UDI-Device Identifier: 00889024590373
• UDI-Public: (01)00889024590373(17)270726(10)3121925
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: Lay User/Patient
• Device Catalogue Number: 0100121050
• Device Lot Number: 3121925
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• 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
• Patient Sex: Unknown