MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CUP POSITIONER; HIP INSTRUMENT

Model Number N/A

Device Problem Separation Failure (2547)

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

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for the investigation.Once the investigation have been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01103.

Event Description

It was reported that during an initial total hip arthroplasty, the cup would not disengage from the cup introducer.There was no reported harm or injury to the patient.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.Reported event was unable to be confirmed due to limited information provided by the customer.A photo was received and review does not confirm the event as the cup is not attached to the instrument.From the image, there are indentations on the handle consistent with a multiple-use device.The dhr was reviewed and no discrepancies were found.The root cause is unable to 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.

Event Description

No additional event information to report at this time.

Event Description

It was reported that during an initial hip procedure, two different cups would not disengage from the cup introducer.There was no harm or injury to the patient.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.00875705801 ¿ continuum cup ¿ 63523377.00875705801 ¿ continuum cup ¿ 64148560.An updated investigation is in process and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02575.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional information does not change the conclusions of the previous investigation.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: CUP POSITIONER
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9888202
• MDR Text Key: 188251817
• Report Number: 0001822565-2020-01101
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00626001800
• Device Lot Number: 61619021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP