MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X300MM INTLKNG DIST; PROSTHESIS, HIP

Catalog Number	11-302015
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a revision due to a fractured stem and an infection.All of the implants were removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).D4 - two device ids were provided by the reporter; it is unknown which exact device was explanted it is one of the following: item#: 11-302015, lot#: 553560.510k: k100469, pro code: kwa.Or item#: 11-301915, lot#: 926470.510k: k100469, pro code: kwa.G2: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
No additional event information to report at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04) ¿ stem.One shell, one liner, one stem, and two plates were returned and evaluated.Upon visual inspection, the stem has fractured at the hole location along with having porous coating missing.Most of the fracture surface appears to be smeared.Artifacts in the non-smeared region in the center of the stem fracture.Fatigue striations identified in the non-smeared region suggest a fatigue mode of failure.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.The patient has an arcos interlocking stem (2021 implant) which has broken in the middle portion of the stem.The complaint is confirmed via the evaluation of the returned product.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause is unable to 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection 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 information is available at the time of this report.

• Brand Name: ARCOS 15X300MM INTLKNG DIST
• 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: 17630501
• Report Number: 0001825034-2023-01968
• Device Sequence Number: 18065342
• Product Code: KWA
• UDI-Device Identifier: 00880304468061
• UDI-Public: (01)00880304468061(17)310125(10)553560
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 05/29/2025

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: 11-302015
• Device Lot Number: 553560
• 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: 01/25/2021
• Supplement Date Received by Manufacturer: 08/24/2023; 01/11/2024; 05/16/2025
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/19/2023; 01/16/2024; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female