MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 13X150MM SPL TPR DIST; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: canada.The 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.
Event or Problem Description
It was reported the patient underwent a hip procedure on an unknown date.Subsequently, the patient underwent a revision due to a fractured stem.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.H6: component code: mechanical (g04) stem.No product was returned; however, a picture was provided.A visual examination of the provided picture identified that the stem fractured into 3 pieces.The distal stem had bio debris between the vertical ridges of the component.No product was returned; further visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records and lot identification was not provided.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is a fracture of the femoral implant at the level of the lesser trochanter with varus malalignment and the proximal femoral implant appears loose.Five proximal femoral cerclage wires are intact.There is no acute osseous fracture or dislocation.Thickening of the proximal femoral diaphysis is likely related to a prior chronic healed fracture.A definitive root cause cannot be determined.Based on the medical image review, the complaint is 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.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4;d1;d4;d9;d10;g3;h2;h3;h4;h6;h10.The following section was corrected: d4;lot number.D10: cat# 11-301321 lot# 634370 arcos con sz a std 70mm.H6: component code: mechanical (g04) - stem.Product was returned and evaluated.Visual examination of the returned products identified the that cone body was confirmed fractured.The proximal stem was seated in the distal fractured piece of the cone body.The cone body shows indentations and gouges to the neck and head taper.The distal stem was returned in two pieces.The provided x-ray showed that the stem was not fractured and it may have been sectioned during explant.The stem also showed tool marks, indentations, and gouges.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there was a fracture of the femoral implant at the level of the lesser trochanter with varus malalignment and the proximal femoral implant appeared loose.Five proximal femoral cerclage wires were intact.There was no acute osseous fracture or dislocation.Thickening of the proximal femoral diaphysis is likely related to a prior chronic healed fracture.A definitive root cause cannot be determined.Based on the returned product review and medical image review, the complaint was 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: ARCOS 13X150MM SPL TPR 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: 20211939
• Report Number: 0001825034-2024-02200
• Device Sequence Number: 18093005
• Product Code: KWA
• UDI-Device Identifier: 00880304480414
• UDI-Public: (01)00880304480414(17)260212(10)909260
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2025

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 Expiration Date: 02/12/2026
• Device Model Number: N/A
• Device Catalogue Number: 11-300813
• Device Lot Number: 909260
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 08/12/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/01/2024; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2016
• 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: Hospitalization; Required Intervention
• Patient Sex: Male