MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER 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)

Patient Problem 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.No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were not provided.The reported products were reviewed for compatibility with no issues noted.The reported issue cannot be confirmed.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03586, 0001822565-2023-03590, and 0001822565-2023-03591.

• Brand Name: ZIMMER BONE SCR 6.5X50 SELF-TAP
• Type of Device: PROTHESIS, 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: 18952578
• MDR Text Key: 338270088
• Report Number: 0002648920-2024-00084
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• UDI-Public: (01)00889024119857(17)280930(10)64179977
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2018
• 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