MAUDE Adverse Event Report: ZIMMER BIOMET, INC. Z1 HO COL CMTLESS SZ 4; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Catalog Number	611202040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 28mm i.D.42mm o.D.Size e bearing, item: 110031011, lot: 67391168, biolox⮠delta, ceramic femoral head, l, 㸠28/+3.5, taper 12/14, item: 00877502803, lot: 3235672.H6: proposed component code: mechanical (g04)- drill.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 that the patient underwent a left hip revision due to a bone fracture.It was noted that the patient experienced a post-operative fall, resulting in a fractured femur and compromised motor skills.It was confirmed that no further information could be provided.
Event or Problem Description
No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.Visual examination of the provided pictures identified the explanted stem covered in bio-debris.No further product evaluation could be made from the provided pictures.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic intertrochanteric fracture is present.There appears to subsidence of the femoral stem and there is periprosthetic radiolucency at the femoral stem bone-metal interface is consistent with loosening.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 trends.

• Brand Name: Z1 HO COL CMTLESS SZ 4
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
• 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: 25215914
• Report Number: 0001822565-2026-01621
• Device Sequence Number: 9792874
• Product Code: LZO
• UDI-Device Identifier: 00887868575624
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K233476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: 611202040
• Device Lot Number: ZB2500998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female