MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HIGH INSIGNIA COLLARED HIP STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	7000-6601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: cat#; device name; lot#: 6260-4-122;22.2mm, std v40 head; 20162054 7236-2-244; restoration adm x3 ins 22/44; 80347a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following information was provided: revision.Reason unconfirmed.Left hip.An insignia stem, metal femoral head, and mdm poly insert were revised to an exeter stem, metal femoral head, mdm poly insert, and competitor cement.

• Brand Name: HIGH INSIGNIA COLLARED HIP STEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 24676499
• Report Number: 0002249697-2026-00236
• Device Sequence Number: 10331617
• Product Code: JDI
• UDI-Device Identifier: 07613327511598
• UDI-Public: 07613327511598
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: Health Professional
• Device Catalogue Number: 7000-6601
• Device Lot Number: 99451402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female