MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC®, SL STEM, OFFSET, UNCEMENTED, 5, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item # 00877504002, biolox delta head 12/14 40x0, lot # 3160761.Item # 30124006, g7 vit e high wall lnr 40mm f, lot # 66098678.Item # 010000665, g7 pps ltd acet shell 56f, lot # 7440511.Item # 98000100129, pr prm st/g7 cp/ve ln/cer/ins, lot # unknown.G2: report source us.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of all relevant device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item and no additional related complaints for the reported part lot combination.Based on the available information, the reported event cannot be confirmed with the available information, 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.
Event or Problem Description
It was reported patient underwent hip revision post implantation due to the stem subsiding.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ALLOCLASSIC®, SL STEM, OFFSET, UNCEMENTED, 5, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• 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: 20064539
• Report Number: 0009613350-2024-00402
• Device Sequence Number: 18349534
• Product Code: JDI
• UDI-Device Identifier: 00889024590373
• UDI-Public: (01)00889024590373(17)250630(10)3038531
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2024

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 Expiration Date: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 0100121050
• Device Lot Number: 3038531
• 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: 08/08/2024
• Initial Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown