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 Material Erosion (1214); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 11/18/2022

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.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before (b)(6), 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.

Event Description

The following was reported: revision for trunnionosis.Noticed from head dissociation.Trunion mis shaped, liner wore down, black residue.Right hip.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed via provided photographs.Method & results: product evaluation and results: visual inspection of the provided photographs indicated that the trunnion of the stem is severely worn consistent with loss of taper lock.The metal head is covered in blood and appears to have damage from the disassociation event and explantation.Material analysis, functional, and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records by clinical consultant indicated " this patient underwent a primary cementless right total hip arthroplasty and 12 years later was revised for trunnionosis and femoral head disassociation.I can confirm that the femoral component, modular femoral head, and acetabular liner were explanted.I was able to see photographs of them on the back table.I cannot confirm anything about the revision since i have no office notes, operation note or post revision x-ray.The causes of trunnionosis and femoral head disassociation are multifactorial including surgical technique factors, patient factors such as bmi and activity level, and implant factors.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.Conclusions: the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa was initiated for the lfit v40 cocr heads within scope of nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

Event Description

The following was reported: revision for trunnionosis.Noticed from head dissociation.Trunion mis shaped, liner wore down, black residue.Right hip.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15963981
• MDR Text Key: 305330588
• Report Number: 0002249697-2022-01805
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/18/2023

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: 10/31/2015
• Device Model Number: 6260-9-236
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MJNT2N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male