MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ANATO STEM SZ 6 LEFT NEUT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	4845-7-216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following device were also listed in this report: device name# ti sleeve for alumina head; cat# 17-0000e; lot# jjr5tj7.It cannot be determined which, if any of these device may have caused or contributed to the patient's experience.
Event or Problem Description
The following information was provided: periprosthetic infection.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving an anato stem was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: insufficient medical records were received for review with a clinical consultant -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: it was reported that the patient was revised due to 'periprosthetic infection; acetabular components are noted to be competitor devices'.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Correction: b3.H11 - lot# jr5tj7.
Event or Problem Description
Periprosthetic infection; acetabular components are noted to be competitor devices.

• Brand Name: ANATO STEM SZ 6 LEFT NEUT
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23107182
• Report Number: 0002249697-2025-01004
• Device Sequence Number: 10143440
• Product Code: JDI
• UDI-Device Identifier: 07613252631330
• UDI-Public: 07613252631330
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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 Expiration Date: 09/30/2022
• Device Catalogue Number: 4845-7-216
• Device Lot Number: 60125302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2017
• 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: Other
• Patient Age: 77 YR
• Patient Sex: Unknown