MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign country: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2020-04097, 0001825034-2020-04099.

Event Description

It was reported that during an initial tha, while implantation of cup g7 osseoti, surgeon tried unscrewing cup impactor from cup, and it wouldn¿t unscrew.Surgeon used more strength, and instead of unscrewing, the ball of the ball hex driver broke in the shaft of the straight impactor, and cup was still screwed to impactor.The tip of the ball hex driver was not found.A thorough search was made in patient, on instruments table, and on the floors.An fluoroscopy ( live x-ray) was made after case to confirm that the tip of ball hex driver was not in patient.Surgeon is confident that it was not in patient.The surgery was completed with another device.Surgeon was able after case to unscrew cup from impactor, using regular driver, from under the cup.The thread of impactor was intact, the thread of cup was intact and the square of impactor was intact as well.No extra strength was needed to unscrew cup from impactor, from under the cup.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were not provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

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

• Brand Name: UNKNOWN CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10833345
• MDR Text Key: 217448944
• Report Number: 0001825034-2020-04098
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• 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: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET BALL HEX DRIVER CAT#010002736 LOT#473382; UNKNOWN INSERTER
• Patient Age: 62 YR