MAUDE Adverse Event Report: ZIMMER BIOMET, INC. Z1 STD COL CMTLESS SZ 1; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the calcar cracked upon implantation.No known consequences or impact on the patient.
Additional Manufacturer Narrative
(b)(4) d10: 611777510 z1 starter broach unknown , 611889000 z1 broach sz 0 unknown , 611889010 z1 broach sz 1 unknown.Suggested component code- mechanical (g04): stem.Product has been received by zimmer biomet and 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 that the surgeon was implanting a z1 stem when the femur was cracked in the medial posterior region of the calcar.It was noted that the stem sat approximately 4cm proud when inserted by hand prior to impaction and was about 8mm proud when the fracture occurred during impaction.A competitor stem was used to complete the surgery.No additional event information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a1, a3, a5, b1, b2, b4, b5, g3, g6, h1, h2, h3, h6, h10, h11.Visual examination of the returned product identified the size engraving is conforming for all 3 broaches.The stem has scratches, indentations, and gouges on the neck and trunnion surfaces.There are also multiple chips to the visible ha coating on the distal tip.All 3 broaches have scratches around the post and nicks on the cutting teeth and broach connection end.No other damage was noted during visual evaluation.All devices where conforming to specifications where measured.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined for the stem causing the fracture upon implantation.No problem was found with the broaches.They came back and measured within specification, with minor damage noted to the cutting edges.The surgical technique was followed and the surgeon broached sequentially up to the size of the definitive implant.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: Z1 STD COL CMTLESS SZ 1
• Common Device Name: PROSTHESIS, HIPS
• 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: 23592429
• Report Number: 0001822565-2025-04214
• Device Sequence Number: 9924997
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K233476
• Number of Events Summarized: 1
• Summary Report (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): 04/20/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 611201010
• Device Lot Number: 67448102
• Date Returned to Manufacturer: 10/30/2025
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female