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

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown hybrid inserter ¿ unknown part and lot.Report source (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.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 - 03070.

Event Description

It was reported that during a hip procedure, the shell could not be firmly fixed into the hybrid shell inserter.The shell was still able to be implanted successfully with no harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6 reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.Tolerance analysis of the interaction between the inserter and the shell confirmed that the devices are compatible and can be fixed properly to each other.Dhr review of the shell confirmed that the thread form and minimum thread depth of the threaded polar hole was 100% inspected per m.I.S at the time of manufacture.However, with the information provided, 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: TRILOGY SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10460670
• MDR Text Key: 204594384
• Report Number: 0001822565-2020-03069
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024172371
• UDI-Public: (01)00889024172371
• Combination Product (y/n): N
• PMA/PMN Number: K980711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 65620004820
• Device Lot Number: 64577318
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10