MAUDE Adverse Event Report: ZIMMER GMBH FITMORE HIP STEM A SIZE 10; PROSTHESIS, HIP

Catalog Number	01.00551.110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Unequal Limb Length (4534)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 10017332, g7 bispherical shell 52e, lot 684909001.00-8775-036-02, biolox delta head 12/14 36x0, lot 3052557.110003634, biolox delta cer lnr 36mm e, lot 3068609.G2: foreign - event occurred in austria.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient had an initial right total hip arthroplasty due to perthes disease and was revised two years later due to limb length discrepancy, pain, and loosening of the acetabular shell.No medical records have been provided; however, the patient alleges that the initial surgeon did not adhere to proper surgical technique.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b7, g3, g6, h2, h3, h4, h6, h10, h11.Corrected data: h6 component codes.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.The reported products were reviewed for compatibility, with no issues noted.Review of the complaint history for the stem found no additional related complaints for this item and the reported part and lot combination.Review of the complaint history for the head identified additional similar complaints for the reported item, and no additional similar complaints for the reported part and lot combination.Complaints are monitored per (b)(4) complaint trending process in order to identify potential adverse trends.Medical records were provided and reviewed by a health care professional.The review identified perthes disease with pre-existing lld of 2.5cm as contributing factors to the event.Patient alleges that the surgeon did not adhere to the manufacturer's specifications and therefore the pan could not grow in at all.He also states that his right left was 2.5cm shorter than left and that the surgeon should not compensate for the leg length difference by more than 75%.Furthermore, the leg shortening was not compensated for by about 75%, as agreed preoperatively, which would have been a length compensation of 1.875 cm (the leg was 2.5 cm shorter), but patient leg, which had previously been 2.5 cm shorter, was then 1.5 cm longer.So dr.Brunner extended it for patient by 4 cm.Patient also alleges that the cup did not come in complete contact with the bone and was neither screw, cemented, or covered resulting in immediate micromotion of the shell preventing osseointegration.Patient provides imaging and personal review/explanation of deviations from the surgical technique.Patient reports revision of the cup due to pain and loosening.A definitive root cause could not be determined.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
There is no update to the prior event description provided.

• Brand Name: FITMORE HIP STEM A SIZE 10
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23669786
• Report Number: 0009613350-2025-00896
• Device Sequence Number: 9808146
• Product Code: KWY
• UDI-Device Identifier: 00889024482678
• UDI-Public: (01)00889024482678(17)300430(10)3029588
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K192236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 01.00551.110
• Device Lot Number: 3029588
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 93 KG