MAUDE Adverse Event Report: ZIMMER BIOMET, INC. Z1 HIP SYSTEM; PROSTHESIS, HIP

Catalog Number	611201070
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unequal Limb Length (4534)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stem subsided post-op.Competitor distal reamers were used.Unknown if a revision will be planned.There is no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).H6: suggested component code: mechanical (g04) ¿ stem.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a4; b5; b7; g3; h2; h6 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 stem subsided post-op an unknown amount, however the patient feels short on the operative side.Competitor distal reamers were used.No known treatment or intervention has taken place.There is no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed.Not submitted to mmi for further assessment.Only 1 of the 2 xrays is dated, from the initial post-op day.Subsidence is difficult to assess from a single time point.It is not possible to call out without a subsequent comparative image and, as such, submission would not enhance the investigation.A definitive root cause cannot be determined.However, the use of reamers from a competitor¿s system to prepare the femur may have contributed to the reported event.This complaint cannot be confirmed.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 for trends.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: Z1 HIP SYSTEM
• 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: 21882083
• Report Number: 0001822565-2025-01102
• Device Sequence Number: 8631966
• Product Code: LZO
• UDI-Device Identifier: 00887868575525
• UDI-Public: (01)00887868575525(17)290723(10)ZB2400159
• 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
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2025

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: 611201070
• Device Lot Number: ZB2400159
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 08/06/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/02/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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
• Patient Sex: Male
• Patient Weight: 121 KG