MAUDE Adverse Event Report: ZIMMER BIOMET, INC. Z1 STD COL CMTLESS SZ 3; PROSTHESIS, HIP

Catalog Number	611201030
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).H6: proposed component code: mechanical (g04) - stem.The reported product has been returned for a technical evaluation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the surgeon stated the size 3 z1 stem didn't feel right after broaching to a 3.No adverse events have been reported as a result of the malfunction.No additional information available for the reported event.
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 visual examination of the returned product identified superficial scratches and discoloration are present on the stem, porous coating, and ha coating from use in the field.No other damage was noted.Where measured, the device was conforming to specifications.Review of the device history records identified no deviations or anomalies during manufacturing.No problem was found with the returned device.The stem measured conforming to specifications.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 3
• 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: 23003204
• Report Number: 0001822565-2025-03341
• Device Sequence Number: 21104713
• Product Code: KWY
• UDI-Device Identifier: 00887868575488
• UDI-Public: (01)00887868575488(17)300527(10)ZB2500764
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K233476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 611201030
• Device Lot Number: ZB2500764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• 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
• Patient Sex: Female