MAUDE Adverse Event Report: ZIMMER BIOMET, INC. Z1 STD COL CMTLESS SZ 6; PROSTHESIS, HIP

Catalog Number	611201060
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the final stem implantation perched a couple millimeters.The surgeon noted that the pps coating is thick and needs to be reduced to allow accurate 1:1 broach to stem.No additional information available for the reported event.
Additional Manufacturer Narrative
(b)(4).D10: biolox delta hd 12/14 36x+3.5.Item: 00-8775-036-03.Lot: 3235665.36mm i.D.Size f neutral liner.Item: 30103606.Lot: 67352087.G7 pps ltd acet shell 54f.Item: 010000664.Lot: j7777524.Pr z1 st/g7 cp/ve ln/cer hd.Item: 98-0005-003-04.Lot: unknown.H6: proposed component code: mechanical (g04) ¿ stem the customer has indicated that the product remains implanted.Once the investigation has been completed, a supplemental mdr will be submitted.
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: g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records 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: the images show a small gap between the calcar and collar of the femoral stem which would coincide with surgeon report of a perched stem.It is not possible to determine if the pps coating is the cause from these images-per the literature, perfect calcar-collar contact is achieved in less than 50% of collared stems and there are several possible causes for improper collar-calcar contact including (but not limited to) low femoral osteotomy or rotation of the component in relation to the final broach.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 STD COL CMTLESS SZ 6
• 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: 23292732
• Report Number: 0001822565-2025-03738
• Device Sequence Number: 17365731
• Product Code: LZO
• UDI-Device Identifier: 00887868575518
• UDI-Public: (01)00887868575518(17)300327(10)ZB2500689
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K233476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 611201060
• Device Lot Number: ZB2500689
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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
• Patient Sex: Male