MAUDE Adverse Event Report: ZIMMER, INC. VERSYS; TEMPLATE

Model Number 7895-36-02

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/22/2020

Event Type  Injury  

Event Description

The patient admitted to the medical center for a right total hip arthroplasty.During the procedure on [date redacted], the plastic provisional trial head dislodged from trial neck/stem while reducing the hip.The surgeon made multiple attempts to retrieve the trial head, but was unsuccessful.The procedure was completed at 1223 the patient was sent to recovery.While in recovery, a trauma surgeon was consulted about the retained item.The patient was brought back to surgery the same day at 1729 and the retained item was removed.The patient tolerated the procedures well.

• Brand Name: VERSYS
• Type of Device: TEMPLATE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• MDR Report Key: 10747550
• MDR Text Key: 213429219
• Report Number: 10747550
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7895-36-02
• Device Catalogue Number: 00-7895-036-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention