MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 70MM; PROTHESIS, HIP

Catalog Number	11-301321
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
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d1;d4;d9;g3;g4;h2;h3;h4;h6;h10.The following section was corrected: d10.D10: cat# 11-300813 lot # 909260 arcos 13x150mm spl tpr dist.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.
Additional Manufacturer Narrative
(b)(4).G2: foreign: canada.D4: attempts have been made to gather all product identification information, and no further information has been provided.D10: cat# 11-300812 / lot# unknown arcos 12x150mm spl tpr dist.Product has been received by zimmer biomet and 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 the patient underwent a hip procedure on an unknown date.Subsequently, the patient underwent a revision due to a fractured stem.The neck was returned and was also noted to be fractured.Attempts have been made, and no further information has been provided.

• Brand Name: ARCOS CON SZ A STD 70MM
• Common Device Name: PROTHESIS, 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: 22410730
• Report Number: 0001825034-2025-01974
• Device Sequence Number: 13184842
• Product Code: KWA
• UDI-Device Identifier: 00880304474314
• UDI-Public: (01)00880304474314(17)260203(10)634370
• 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
• 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: 02/03/2026
• Device Catalogue Number: 11-301321
• Device Lot Number: 634370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male