MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 6; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00875505202 allofitâ®-s it alloclassicâ®, shell for acetabulum, uncemented, 52/ii lot number 3097158.00877501036 bioloxâ® delta ceramic taper liner, size ii / 36 i.D.For use with 52 mm o.D.Size ii shell lot number 3087512.00877503602 bioloxâ® delta, ceramic femoral head, m, 㸠36/0, taper 12/14 lot number 3095862.Report source: foreign: germany.Proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A ct scan was provided but not sent for review as additional ct slices are needed for a complete picture of the reported issue.Other medical records and mri provided were for the knee.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.
Event or Problem Description
It was reported patient underwent initial hip arthroplasty.Subsequently the patient experienced necrosis and loss of activity approximately one year post implantation.Review of ct scan shows possible implant fracture.No revision has been reported to date.There is no additional information available at the time of this report.

• Brand Name: FEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 6
• Common Device Name: PROSTHETIC, 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: 16744221
• Report Number: 0001822565-2023-01049
• Device Sequence Number: 20177903
• Product Code: LWJ
• UDI-Device Identifier: 00889024508798
• UDI-Public: (01)00889024508798(17)260331(10)3066887
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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 Expiration Date: 03/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 574102060
• Device Lot Number: 3066887
• 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: 04/14/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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; Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 105 KG