MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 56MM O.D. SIZE KK POROUS UNCEMENTED SHELL; PROSTHESIS, HIP

Catalog Number	00875705601
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the bone screw was used according to the surgical technique, however it passed through the pre-drilled hole in the shell.When the screw was retrieved, it was noticed that the head of the screw was broken off.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: 00625006535 / trilogy bone scr 6.5x35 / j7583517.G2: canada.Multiple mdr reports were filed for this event, please see associated reports: screw: 0001822565-2024-00209.Visual examination of the returned product identified screw is fractured around the circumference of the head.Fractured piece(s) were not returned for evaluation.Hex shows nicks and gouges from use.Distal threads and taper below head show deformation and witness marks from insertion.No other damage was noted.Visual review of the shell tm surface and inner spherical surface show bio debris, nicks, and scratches from attempting to implant.Cluster holes note one hole with damage from the screw.Tm pad is deformed around the hole from the screw passing through.The metal side of the hole shows deformation.No other damage was noted.This complaint was confirmed based on the damage to the shell hole indicating the screw passed through.Dhr was reviewed and no discrepancies related to this reported event were found.A definitive root cause cannot be determined.It is unknown whether the screw broke during insertion causing the fit/mate issue, or the screw broke during explant.The surgeon only noted it was broken after it was retrieved.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: 56MM O.D. SIZE KK POROUS UNCEMENTED SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19221040
• Report Number: 0001822565-2024-01442
• Device Sequence Number: 20881512
• Product Code: JDI
• UDI-Device Identifier: 00889024151437
• UDI-Public: (01)00889024151437(17)330614(10)66008775
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00875705601
• Device Lot Number: 66008775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Unknown