MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 4; PROSTHESIS, HIP

Catalog Number	574102040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: netherlands.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that a patient experienced a per-prosthetic fracture.Attempts have been made and no further information is available.
Event or Problem Description
It was reported that a patient underwent a hip revision approximately one day post implantation due to a periprosthetic fracture.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1; a2; a3; a4; b4; b5; b7; d6b; g3; h2; h6.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.G2: norway.Proposed code: mechanical (g04) ¿ stem.No product was returned or pictures provided; visual and dimensional evaluations could not be confirmed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: spinal anesthesia, sciatic nerve spared, trial implants good stability, joint irrigated and closed.One day post-op, the patient sustained a periprosthetic fracture and was revised.Patient revised and implant thrown away.Removal of stem and lateral plate.No medical records provided regarding revision.The complaint was unable to be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.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.

• Brand Name: FEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 4
• 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: 20450099
• Report Number: 0001822565-2024-03266
• Device Sequence Number: 20986743
• Product Code: LZO
• UDI-Device Identifier: 00889024508774
• UDI-Public: (01)00889024508774(17)280126(10)3139336
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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,Followup,Followup
• Report Date (Section B): 01/24/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 574102040
• Device Lot Number: 3139336
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 01/17/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/13/2024; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 93 KG