MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X190MM SPL TPR DIST; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately six years post implantation of a right total hip arthroscopy, the patient was walking at a normal speed, when he heard a pop which sounded like a champagne glass shattering on the ground.Subsequently, the patient was revised, and it was determined that the stem and modular cone body had broken above the taper junction.There were no contributing conditions related to the event.No additional information was available.
Additional Manufacturer Narrative
(b)(4).D10: cat# 103534 lot# 919850 ti low profile screw 6.5x35mm.Cat# 163670 lot# 792050 32mm mod head cocr +3mm neck.Cat# 103533 lot# 521940 ti low profile screw 6.5x30mm.Cat# pt-106058 lot# 148990 regen/rnglc+ multi 58mm sz 24.Cat# xl-105924 lot# 586310 arcomxl 32mm rlc lnr hw sz24.Cat# 103533 lot# 254130 ti low profile screw 6.5x30mm.Cat# 103532 lot# 444340 ti low profile screw 6.5x25mm.Cat# 11-301351 lot# 509670 arcos con sz a hi 80mm.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
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 information.The following sections were updated: b4;d4;g3;h2;h3;h4;h6;h10.H6: component code: mechanical (g04) stem.Product was not returned for evaluation; however, photos were provided and reviewed.A visual examination of the provided pictures identified that the proximal body and distal stem had fractured.The items were covered in bio-debris.No further evaluation could be made from the provided photos.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 but were not reviewed by a health care professional due to poor quality of the photocopy image which would not be diagnostic.Additionally, explant photos provided sufficient evidence of failure.Sending the images would not enhance the investigation.A definitive root cause cannot be determined.The complaint was confirmed based on provided photos that showed the fractured explanted devices.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.

• Brand Name: ARCOS 15X190MM SPL TPR DIST
• 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: 19885634
• Report Number: 0001825034-2024-01959
• Device Sequence Number: 4144695
• Product Code: KWA
• UDI-Device Identifier: 00880304480513
• UDI-Public: (01)00880304480513(17)250725(10)713580
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 07/25/2025
• Device Model Number: N/A
• Device Catalogue Number: 11-300915
• Device Lot Number: 713580
• 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: 07/13/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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