MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER BONE SCR 6.5X50 SELF-TAP; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0002648920-2024-00084
• Device Sequence Number: 7084628
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• UDI-Public: (01)00889024119857(17)280930(10)64179977
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female