MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MICRO CAP FOR TRILOGY CUP POSITIONER; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

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

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00626001800, cup positioner, 62207042.65875306001, shell with cluster holes porous 60 mm o.D.Size mm for use with mm liners with calcicoat ceramic coating, 63271280.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 02181, 0001822565 - 2018 - 02182 (b)(6).Complaint sample was evaluated and the reported event was confirmed.Complaint sample was evaluated and the reported event was confirmed.A significant amount of force was applied with hand to disassemble the whole construct.Visual inspection of the shell identified impaction marks from the micro cap around apex hole.Visual inspection of the cup positioner identified superficial scratches on the handle body with no other damage.Visual inspection of the micro cap identified wear on the mating surface.The thread form of the cup positioner and the shell passed go and no go gages.The cup positioner has a field service age of 5.5 years.It is unknown how many times the positioner was used other shells.Dhr was reviewed and no discrepancies were found.The most likely root cause of the reported event can be contributed to the incompatible micro cap was used during the surgery.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

It was reported that the cup would not disengage from the introducer.The surgery was completed with a backup product.There was a surgical delay of ten minutes.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: MICRO CAP FOR TRILOGY CUP POSITIONER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8417868
• MDR Text Key: 138772941
• Report Number: 0001822565-2019-01100
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• 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: 00879000320
• Device Lot Number: 61709151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1