MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Insufficient Information (4580)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: the physician reported that an inflammatory response was observed in a patient who had the accolade¿ tmzf implanted.According to the examination results, infection was ruled out (negative).At this time, no further information is available.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving an accolade 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 remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: complaint reports ¿inflammatory response¿ involving catalog # 6021-0335; accolade plus tmzf hip stem # 3; lot/serial # unknown.Based on available information, there is no confirmation of this inflammation or involvement of the hip implant.The synovial fluid was collected on the right side and the clinical note references pain on the left side without any imaging changes.The positive finding on the laboratory studies is a urinary tract infection that is unrelated to the hip prosthesis.The reported event is not confirmed and there is no root cause to investigate.As no adverse event is confirmed, there are no device, procedure, or patient related factors to evaluate.-product history review: a review of the device history records could not be performed as lot code information was unknown.-complaint history review: a complaint history review could not be performed as lot code information was unknown.Conclusions: it was reported that at an inflammatory response was observed in a patient who had the accolade¿ tmzf implanted.According to the examination results, infection was ruled out (negative).A review of the provided medical records by a clinical consultant indicated: complaint reports ¿inflammatory response¿ involving catalog # 6021-0335; accolade plus tmzf hip stem #3; lot/serial # unknown.Based on available information, there is no confirmation of this inflammation or involvement of the hip implant.The synovial fluid was collected on the right side and the clinical note references pain on the left side without any imaging changes.The positive finding on the laboratory studies is a urinary tract infection that is unrelated to the hip prosthesis.The reported event is not confirmed and there is no root cause to investigate.As no adverse event is confirmed, there are no device, procedure, or patient related factors to evaluate.No further investigation for this event is possible at this time.If device and/or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 24363027
• Report Number: 0002249697-2026-00104
• Device Sequence Number: 15901356
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 6021-0335
• Device Lot Number: UNKNOWN
• 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): Initial
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 127 LB