MAUDE Adverse Event Report: DEPUY SYNTHES, INC. ACETABULAR TRIAL RETAINING RING TRIAL LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2016

Event Type  malfunction  

Event Description

The acetabular trial retaining ring washer is inside a patient's hip joint.This is a part of the stainless steel piece of the depuy acetabular liner trial instrumentation.Manufacturer response for depuy acetabular trial retaining ring, depuy (per site reporter): depuy sales rep notified hospital operating room director and risk manager.He stated this is not the first time the instrumentation has come apart/broken.He was not aware of any situation where this led to a retained foreign object.The screw has come apart before but not during the actual case.Sales rep stated he has submitted several reports to his company.This is the first time, he has made a report to the facility.I will submit a picture of the acetabular trial used minus the screw component and a picture of the full set.Sales rep gave drm the component used during the case.Sales rep was present during the procedure.

• Brand Name: ACETABULAR TRIAL RETAINING RING TRIAL LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): DEPUY SYNTHES, INC.; 325 paramount dr; raynham, MA 02767
• MDR Report Key: 5837173
• MDR Text Key: 50918509
• Report Number: 5837173
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 36X52MM +4 / 10 DEGREES
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR