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

Model Number 6260-9-236

Device Problems Corroded (1131); Material Erosion (1214); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Ambulation Difficulties (2544)

Event Date 09/12/2022

Event Type  Injury  

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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported to the distributor that during the revision surgery of accolade i its shows severe taper corrosion.As reported: "severe accolade trunnion corrosion led the patients revision surgery and before the surgery the mentioned corrosion has caused severe pain, loss of power and inability to walk.

Manufacturer Narrative

Reported event: an event regarding disassociation and corrosion of a metal head was reported.The event of disassociation and corrosion was not confirmed.Method & results product evaluation and results: visual inspection, material analysis, functional and dimensional inspections could not be performed as the device was not returned.Photos were provided for review, but the images did not contain the head, medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: narrative: as described above, this patient underwent a primary cementless stryker total hip arthroplasty, had 2 dislocations and approximately six years later had to undergo a revision for head neck disassociation and trunnion corrosion and deformity.A competitor product was used for the revision.Conclusion of assessment: this patient developed trunnion corrosion and deformity resulting in head neck disassociation approximately six years following primary stryker total hip arthroplasty.Revision was carried out with a competitor product.The root cause cannot be determined with certainty.The root causes of this event are multifactorial including surgical technique, especially in the mode of preparation of the trunnion and implantation of the femoral head, patient factors including activity level and bmi, and implant factors.I can confirm that the primary procedure and the revision procedure was carried out since i was able to review x-rays and some operation reports.The explanted prosthesis should be submitted to stryker engineers for their analysis.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the event of disassociation and corrosion was not confirmed.Further information such device return 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.

Event Description

It was reported to the distributor that during the revision surgery of accolade i its shows severe taper corrosion.As reported: "severe accolade trunnion corrosion led the patients revision surgery and before the surgery the mentioned corrosion has caused severe pain, loss of power and inability to walk.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Type of Device: 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 NA ; EI NA ; 61498200
• MDR Report Key: 16025664
• MDR Text Key: 305920760
• Report Number: 0002249697-2022-01879
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 6260-9-236
• Device Catalogue Number: 6260-9-236
• Device Lot Number: DL5K15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female