MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40(TM). FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6364-2-036
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Stainless steel head implanted on accolade stem during revision surgery.Surgeon asked for stainless steel -5 head, opened up and implanted.Not noticed/realised error until after case.Surgeon has been notified.
Event or Problem Description
Stainless steel head implanted on accolade stem during revision surgery.Surgeon asked for stainless steel -5 head, opened up and implanted.Not noticed/realised error until after case.Surgeon has been notified.
Additional Manufacturer Narrative
An event regarding the off label use of an orthinox head with an accolade ii stem was reported.Conclusions: it was reported that an exeter metal head was implanted with a an accolade ii stem.No patient harm was reported.A review of the the accolade ii femoral hip system surgical protocol indicated that only the cocr, alumina ceramic, and biolox delta ceramic stryker v40 heads are compatible with the accolade ii stems.Orthinox heads are not listed as a compatible head with the accolade ii stem.The reported event is considered to be the result of user error.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: V40(TM). FEMORAL HEAD
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21730398
• Report Number: 0002249697-2025-00358
• Device Sequence Number: 15703666
• Product Code: LPH
• UDI-Device Identifier: 07613153121992
• UDI-Public: 07613153121992
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: AS
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 6364-2-036
• Device Lot Number: G8411046
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown