MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP MOLD STEM W/REINF 9X125; BONE CEMENT, ANTIBIOTIC

Catalog Number	431190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H10: freedom constr hd 36mm t1 std, item: 11-107018, lot: 67230805.Freedom all poly cup 50mm, item: 11-107122, lot: 67107174.Unknown screws, unknown cement, unknown 3.5mm recon plate & screws.H6: suggested component code: mechanical (g04) - stem.The location of the reported device is unknown; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported, approximately 8 months postop, the patient presented with periprosthetic infection.A first stage revision occurred; all initial implants were removed without apparent complication.After reaming the femoral canal, a nondisplaced fracture in the peritrochanteric region was identified.An unknown 3.5mm reconstruction plate and screws were placed to stabilize the fracture.No further complications were identified.Final intraop x-rays indicated appropriate fracture reduction and implant placement.A cement spacer stem was placed along with an all-poly cup, a cemented constrained liner, and additional screws for fixation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: HIP MOLD STEM W/REINF 9X125
• Common Device Name: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25231005
• Report Number: 0001825034-2026-01356
• Device Sequence Number: 10237948
• Product Code: MBB
• UDI-Device Identifier: 00880304521995
• UDI-Public: (01)00880304521995(17)300219(10)66510982
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K222760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: Lay User/Patient
• Device Catalogue Number: 431190
• Device Lot Number: 66510982
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American