MAUDE Adverse Event Report: BIOMET ORTHOPEDICS, LLC ARCOS MODULAR REVISION SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Model Number 31-301852

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/03/2020

Event Type  malfunction  

Event Description

From staff: surgeon operating on pt's hip and surgical instrument (torque screwdriver) broke.From op report: complications: broken screw driver tip that prolonged case.I was eventually able to remove trial cone body.Initially i could not engage the threads to remove the trial component since the tip of screw driver had sheared off.We attempted to remove entire construct, but the distal stem was well engaged.I irrigated the region where the screw driver is inserted, and this appeared to clear the hole.I was able to engage a new screw driver to loosen the proximal body trial.The articulating surface region was visible inspected as well as palpated.We did not visualize the broken piece within the surgical site.Post-op xrays showed no evidence of the broken piece within the patient's body.Manufacturer response for 3.5 hex screwdriver, (brand not provided) (per site reporter).Zimmer rep took pieces.He was in the room for the case as well.

• Brand Name: ARCOS MODULAR REVISION SYSTEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): BIOMET ORTHOPEDICS, LLC; 56 east bell dr. p.o. box 587; warsaw IN 46581
• MDR Report Key: 10424890
• MDR Text Key: 203469848
• Report Number: 10424890
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31-301852
• Device Catalogue Number: 31-301852
• Device Lot Number: ZB160707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Weight: 117