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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 12/02/2021

Event Type  Injury  

Event Description

It was reported that the patient was revised approximately 20 years post implantation due to dislocation.It was noted the cup was mapped with intellijoint navigation at 70 degrees of abduction which is not close to the recommended parameters.Therefore, the surgeon removed the trilogy acetabular shell and revised to a more desirable position with a new shell, which in theory would prevent the patient from redislocation.Multiple cultures were taken and came back negative for infection.The stem was well fixed and in appropriate position per the surgeon so it stayed.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).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: 0001822565 - 2021 - 03599 , 0001822565 - 2021 - 03600.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6.No product was returned; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: markedly abnormal vertical orientation of the right acetabular cup.Part and lot identification are necessary for review of device history records, neither were provided.The root cause of the related event can be attributed to the cup angle being between 70-90 degrees as noted by the revising surgeon and a review by mmi.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 TRILOGY CUP
• 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: 13017939
• MDR Text Key: 282330414
• Report Number: 0001822565-2021-03598
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/30/2021
• Supplement Dates FDA Received: 12/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention