MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS LATERAL TROCH BOLT 30MM; PROSTHESIS, HIP

Catalog Number 11-302130

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2024

Event Type  Injury  

Event Description

It was reported a patient underwent a hip revision approximately one month post implantation due to a loose claw, bolt and wires.The stem, head and cup remain implanted.The loose parts were removed and a plate was installed on the lateral side to secure fixation.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).D10: cat #: 11-302101 / arcos troch claw large 100mm / lot #: 65688621.Unknown wire x 2.G2: switzerland.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

• Brand Name: ARCOS LATERAL TROCH BOLT 30MM
• Type of Device: 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: 19174125
• MDR Text Key: 340944044
• Report Number: 0001825034-2024-01066
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304474345
• UDI-Public: (01)00880304474345(17)270407(10)760420
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 11-302130
• Device Lot Number: 760420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention