MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A HI 60MM; PROTHESIS, HIP

Catalog Number	11-301311
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 22-300917, lot# 640200 arcos 17x190mm spl tpr dist ha.G2: foreign: country: sweden.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 6 years post implantation of a total hip arthroplasty, the patient was revised due to instability.The patient had an x-ray which showed that the prosthesis had broken off at the neck of the body.There was no known trauma.The patient was described as being active and plays a lot of golf.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: a3; b4; b5; g3; h2; h3; h6; h10; h11.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
Additional information received.It was reported that the fracture site was located after the trunnion at the neck, and only on the body.The event occurred on the left hip.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; d9; d10; g3; h2; h3; h6.D10: cat# unknown lot# j6327166/unknown head.Product returned and evaluated.Visual examination of the returned product identified that the arcos body was confirmed to have what appeared to be a fractured surface in the neck region of the cone body.It also appears that a portion of the same neck region was cutoff.The cone body had scratches and gouges all around between the neck and porous coated regions.The porous coating has foreign debris and gouges present.The neck region of the cone body had nicks, gouges, and scratches.No other damage was noted.The cone body analysis determined fatigue mode of failure on the fracture surface.The lower region of the fracture surface was shiny, smooth, and covered in scratches.The lower region was more likely caused by a cutting instrument.Review of the device history records identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.A definitive root cause cannot be determined.This complaint was confirmed based on the returned, fractured device.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 CON SZ A HI 60MM
• 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: 21459417
• Report Number: 0001825034-2025-00471
• Device Sequence Number: 7781699
• Product Code: KWA
• UDI-Device Identifier: 00880304474086
• UDI-Public: (01)00880304474086(17)280608(10)322500
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted 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
• Report Date (Section B): 07/29/2025

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: 11-301311
• Device Lot Number: 322500
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 07/25/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/18/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2018
• 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