MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA UNI FEMORAL HEAD 16/18 R36 16/18; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6519-1-036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient requires a second revision surgery due to ongoing discomfort experienced with a stryker ceramic femoral head & socket.The second revision is scheduled for (b)(6) 2025.The patient's initial implant surgery was in (b)(6) 2019 and the first revision was performed in (b)(6) 2024.It was further reported that during the first revision, the surgeon replaced the accolade head with a stryker ceramic femoral head and a new socket.The original stem from 2019 was not replaced.
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient requires a second revision surgery due to ongoing discomfort experienced with a stryker ceramic femoral head & socket.The second revision is scheduled for (b)(6) 2025.The patient's initial implant surgery was in (b)(6) 2019 and the first revision was performed in (b)(6) 2024.It was further reported that during the first revision, the surgeon replaced the accolade head with a stryker ceramic femoral head and a new socket.The original stem from 2019 was not replaced.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a ceramic head was reported.The event was not confirmed.Method & results: product evaluation and results: the head was returned for evaluation.Explantation damage observed on the surface of the device.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that the patient was revised due to pain.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary/revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: DELTA UNI FEMORAL HEAD 16/18 R36 16/18
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 21898643
• Report Number: 0002249697-2025-00436
• Device Sequence Number: 8082681
• Product Code: LZO
• UDI-Device Identifier: 04546540608437
• UDI-Public: 04546540608437
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 6519-1-036
• Device Lot Number: 11112151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 07/26/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 24 KG