MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PROVISIONAL STEM; PROSTHETIC, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: unknown day in september, 2020.Implant date: unknown day in september, 2020.Explant date: unknown day in september, 2020.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03877.

Event Description

It was reported that during right total hip arthroplasty the plastic trial head dislodged from the trail neck/stem while reducing the hip.The surgeon made multiple attempts to retrieve the trail head but was unsuccessful.The procedure was completed and the patient sent to recovery.While in recovery, a trauma surgeon was consulted and the patient was brought back to surgery the same day and the retained item was removed.The patient tolerated the procedures well.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided for the stem provisional.A definitive root cause cannot be determined.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: UNKNOWN PROVISIONAL STEM
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10884691
• MDR Text Key: 217672473
• Report Number: 0001822565-2020-03876
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention