MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 16.25; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Pain (1994)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877503602, lot# 3141157, biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14; cat# 00620205822, lot# 65712881, shell porous with cluster holes 58 mm; cat# 00625006525, lot# j7459469, bone scr 6.5x25 self-tap; cat# 00625006530, lot# 65915092, bone scr 6.5x30 self-tap; cat# 00630505836, lot# 65578308, liner standard 3.5 mm offset 36 mm i.D.For use with 58 mm o.D.Shell.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02683.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported by the surgeon that the patient underwent an initial hip procedure and was revised approximately three months later due to a fall and subsequent periprosthetic femur fracture.There were no reported surgery complications.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} it was reported patient was riding a bike and had a fall from the bike causing the periprosthetic fracture.The components are not related to cause of the fall.A periprosthetic fracture is a break in the bone near or around the site of an implant.During the joint replacement surgery, a series of events occur which compromises the integrity of the long bones around the joint which include reaming, rasping, irrigating, impacting, and drilling.The implant is then inserted and secured into these bones either by cement, press-fit force, or bone matrix integration which can take varying amounts of time to become secure in the bone.As the bone is healing, it is more susceptible to damage and fracture from external trauma such as a hit, fall, or weight-bearing forces.As the complaint indicates the patient experienced a periprosthetic fracture, it can be expected the patient would require additional medical and/or surgical intervention.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
No further information at the time of this report.

• Brand Name: MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 16.25
• 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: 17875535
• Report Number: 0001822565-2023-02685
• Device Sequence Number: 4401178
• Product Code: LPH
• UDI-Device Identifier: 00889024132689
• UDI-Public: (01)00889024132689(17)320308(10)65309738
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K182678
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00771301600
• Device Lot Number: 65309738
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 89 KG