MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM +5 OFFSET; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-236
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: (b)(6).Said patient came into urgent care clinic complaining of pain.(b)(6).Sent me x-ray films taken on (b)(6) 2026 of a patient he performed left total hip arthroplasty on approximately 10 years ago.The implanted femoral head was not on the stem trunnion.The stem appeared to be an accolade 2 and the head appeared to be 36mm cocr.Patient was referred to uams for further treatment and possible surgery.As of this moment, patient has not undergone additional surgery.This patient has been referred to another clinic/surgeon for further evaluation.
Additional Manufacturer Narrative
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
Additional information from duplicate pi: pt.Reported via phone; i've had a hip replacement back in 2016 which was a stryker titanium.On 1/28/2026 i actually went to just have it checked out because several months it's been popping and finally it's gotten to where i can't move around at all and can't go to work and fix things about.When that happened and their x-ray shows that it was broken so i'm just curious as where do i go from here.I've already had it replaced.I had another complete hip replacement 42 reconstruct and took the one that was broken out and then another one put in on my left side.It was a stryker titanium that was implanted on (b)(6) 2016 an axiom to find out that was actually broken whenever to an x-ray other than the pain it could have been broken even earlier than that.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an metal head was reported.The event was confirmed via review of medical records by a clinician.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: a review with a clinical consultant indicated: a failure of an accolade tmzf stem with severe trunnionosis and disassociation of the head from the stem can be confirmed.A revision surgery cannot be confirmed but would be expected.A root cause for the trunnionosis cannot be determined.The disassociation of the head from the stem would be the result of the severe trunnionosis.The anticipated revision would be the result of the trunnionosis and disassociation of the head from the stem.-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 referenced.Conclusions: a review with a clinical consultant indicated: a failure of an accolade tmzf stem with severe trunnionosis and disassociation of the head from the stem can be confirmed.A revision surgery cannot be confirmed but would be expected.A root cause for the trunnionosis cannot be determined.The disassociation of the head from the stem would be the result of the severe trunnionosis.The anticipated revision would be the result of the trunnionosis and disassociation of the head from the stem.No further investigation for this event is possible at this time.If device/additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: V40 COCR LFIT HEAD 36MM +5 OFFSET
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick, FL NA ; EI NA ; +353 9546280700
• MDR Report Key: 24433621
• Report Number: 0002249697-2026-00116
• Device Sequence Number: 10297625
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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 Expiration Date: 02/29/2020
• Device Catalogue Number: 6260-9-236
• Device Lot Number: 612W26
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2015
• 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: 70 YR
• Patient Sex: Male