MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS MODULAR REVISION HIP SYSTEM; PROSTHESIS, HIP

Catalog Number	11-300822
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Cat: 110031011 lot: 66842409 28mm i.D.42mm o.D.Size e bearing cat: 650-1157 lot: 3189493 delta cer fem hd 28/+3mm t1 g2: foreign ¿ australia h6: suggested component code: mechanical (g04) - stem the customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a hip revision due to a periprosthetic fracture post-op.There was internal fixation of the femur.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b1; b5; d4; d6a; g3; h2; h4; h6.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately two weeks post-implantation, the patient underwent a hip revision due to a periprosthetic fracture post-operation and a dislocation as a result of the fracture.There was internal fixation of the femur.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5; g3; h2 the following sections were corrected: h6 device code the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately two weeks post-implantation, the patient underwent a hip revision due to a periprosthetic fracture post-op and a dislocation as a result of the fracture.The bearing and head dislocated.There was internal fixation of the femur.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6 the following sections were corrected: h4 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided.Review of the available records identified the following: a superolateral dislocation.No fracture is identified.A definitive root cause cannot be determined.The complaint is confirmed based on the x-ray findings.Dislocation confirmed; periprosthetic fracture could not be confirmed.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: ARCOS MODULAR REVISION HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21790337
• Report Number: 0001825034-2025-01016
• Device Sequence Number: 18120210
• Product Code: KWA
• UDI-Device Identifier: 00880304474161
• UDI-Public: (01)00880304474161(17)340212(10)66549286
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090757
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/09/2025

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: Health Professional
• Device Catalogue Number: 11-300822
• Device Lot Number: 66549286
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 03/27/2025; 04/22/2025; 06/24/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 04/22/2025; 05/16/2025; 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 70 KG