MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X25 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problems Positioning Failure (1158); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4); concomitant medical products: cat# 00879000703 lot# unk modular flex drill bit 3.2 mm diameter 30 mm length cat# 574202050 lot# 3142207 avenir cmpl ha ho col size 5 cat# 00877502802 lot# 3141226 biolox⮠delta, ceramic femoral head, m, 㸠28/0, taper 12/14 cat# 110010245 lot# 65703642 g7 osseoti 4 hole shell 54mm f cat# 110024464 lot# 65887407 g7 dual mobility liner 44mm fj cat# 110031012 lot# 65851661 vivacit-e dm bearing 28x44mm.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: malposition of the single acetabular fixation screw as noted.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.

Event Description

It was reported that a trilogy screw has gone all the way through the osseoti cup.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

• Brand Name: BONE SCR 6.5X25 SELF-TAP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17151113
• MDR Text Key: 317648489
• Report Number: 0002648920-2023-00125
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119819
• UDI-Public: (01)00889024119819(17)320731(10)65537993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• 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
• Report Date: 06/16/2023

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: 00625006525
• Device Lot Number: 65537993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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
• Patient Sex: Male