MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 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  

Event Description

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

Manufacturer Narrative

(b)(4).D10: 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.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).

• Brand Name: BONE SCR 6.5X25 SELF-TAP
• Type of Device: 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: 17059151
• MDR Text Key: 316509963
• Report Number: 0001822565-2023-01478
• Device Sequence Number: 1
• Product Code: LPH
• 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,Followup
• Report Date: 06/15/2023

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: 05/17/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 06/16/2023
• 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: SEE H10 NARRATIVE.
• Patient Sex: Male