MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW SELF-TAPPING 4.5 MM DIA. 40 MM LENGTH; PROSTHESIS, HIP

Catalog Number	00625004540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: shell porous with multi holes 50 mm: catalog#: 00620205020, lot#: 64553183; liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells: catalog#: 00630505036, lot#: 66229500; bone screw self-tapping 4.5 mm dia.35 mm length: catalog#: 00625004535, lot#: j7545291; bone screw self-tapping 4.5 mm dia.50 mm length: catalog#: 00625004550, lot#: 64157927, qty#: 2; 50mm x 10mm thickness acetabular augment: catalog#: 00489405010, lot#: 65378688.G2: foreign: germany.Visual examination of the provided pictures identified the explanted shell, liner, augment, screws, and head covered in bio-debris.The augment is confirmed to be fractured.The locking ring is sitting slightly outside of the groove.No further evaluation can be made.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fracture of the medial wall of the left acetabulum with mild medial implant migration and cup loosening as noted.Root cause was unable to be determined.Reported event was confirmed by review of provided radiographs and photos of the explanted devices.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a patient underwent an initial total hip arthroplasty.Approximately ten (10) months post-implantation, the patient began to experience pain and the acetabular augment was found to be fractured.The patient underwent revision surgery to replace the affected component without reported complication.Due diligence is complete as multiple attempts have been made; all available information has been provided.

• Brand Name: BONE SCREW SELF-TAPPING 4.5 MM DIA. 40 MM LENGTH
• Common Device Name: 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: 23087797
• Report Number: 0001822565-2025-03477
• Device Sequence Number: 13387512
• Product Code: LPH
• UDI-Device Identifier: 00889024119765
• UDI-Public: (01)00889024119765(17)320819(10)J7329546
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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: Lay User/Patient
• Device Catalogue Number: 00625004540
• Device Lot Number: J7329546
• 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: 08/22/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 97 KG