MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X50 SELF-TAP; PROTHESIS, HIP

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 11/20/2023

Event Type  Injury  

Event Description

It was reported that three days after a right hip revision surgery, the patient required a second revision due to a screw pulling through the acetabular shell with subsequent loosening of the acetabular shell.The surgeon removed the shell and re-implanted a new shell.It was reported that there was no patient injury, no surgical complications, and no foreign body was retained.It is not known whether the patient's condition or anatomy contributed to the event.No additional information.

Manufacturer Narrative

(b)(4).D10: cat# 31-323230, lot# 66103691 3.2mmx30mm rnglc+ acet drl bit.Cat# 00625006530, lot# j7564637, bone scr 6.5x30 self-tap.Cat# 00625006520 ,lot# j7442427 ,bone scr 6.5x20 self-tap.Cat# 00625006515 ,lot# j7583487, bone scr 6.5x15 self-tap.Cat# 30124006, lot# 65875468 ,g7 vit e high wall lnr 40mm f.Cat# 110010266, lot# 65698426 ,g7 osseoti multihole 56mm f.The customer was unable to determine which bone screw pulled through the shell.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565-2023-03586, 0001822565-2023-03590, 0001822565-2023-03591.

Manufacturer Narrative

This follow up is being submitted to relay corrected 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).

Event Description

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 6.5X50 SELF-TAP
• Type of Device: PROTHESIS, 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: 18312444
• MDR Text Key: 330296893
• Report Number: 0001822565-2023-03587
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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
• Device Catalogue Number: 00625006550
• Device Lot Number: 64179977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/21/2024
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female