MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS LATERAL TROCH BOLT 38MM; PROSTHESIS, HIP

Catalog Number	11-302138
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a case where arcos prosthesis was implanted and an arcos trochanteric claw was used.The trocanteric bolt that is used to fix the claw to the proximal body has post operatively backed out of the screw hole.The bolt and claw are still somewhat in place, although the bolt has backed out a bit.The devices are still in situ in this patient.There is no surgery date of the removal of these items.Trochanteric bolt is backing out of the arcos cone proximal body, which causes loosening of the arcos trochanteric claw.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).G2 foreign: netherlands.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; h2; h4; h6.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient had left total hip arthroplasty on an unknown date followed by a revision due to infection.During the revision a trochanteric fracture was found and a large plate and bolt were placed along with cerclage cables for fixation.Subsequently the patient began experiencing pain and swelling.Patient underwent a procedure for possible removal.During the procedure the screw was seen to be still in place but completely loose.The screw was removed.The plate is still well fixed and therefore was not removed.An x-ray image was reviewed and not submitted to radiology as the timeframe does not align with the allegation.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.
Event or Problem Description
It was reported a patient had a left total hip arthroplasty on an unknown date followed by a revision due to infection.During the revision, a trochanteric fracture was found and a large plate and bolt were placed, along with cerclage cables for fixation.Subsequently, the patient began to experience pain and swelling approximately nine (9) months later, underwent a procedure for possible removal.During the procedure, the screw was found completely loose, the plate was well fixed, and a proximal cerclage was broken.The bolt was removed and the plate was retained.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b1, b2, b3, b5, d6, h1, h2, h6, h10.

• Brand Name: ARCOS LATERAL TROCH BOLT 38MM
• 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: 23125655
• Report Number: 0001825034-2025-02985
• Device Sequence Number: 17969737
• Product Code: KWA
• UDI-Device Identifier: 00880304474406
• UDI-Public: (01)00880304474406(17)290409(10)420950
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 01/15/2026

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 Catalogue Number: 11-302138
• Device Lot Number: 420950
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 01/15/2026
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 12/26/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2019
• 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: BIOMET ARCOS STEMITEM: 11300916 LOT: 66552441
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female