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

Catalog Number 6260-9-236

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 09/01/2023

Event Type  Injury  

Event Description

It was reported that the patient arrived in er with discomfort in hip.Component failure discovered upon xray.The head disassociated from the stem.

Manufacturer Narrative

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.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.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 march 4, 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.H3 other text : device not returned to the manufacturer.

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 clinician review of provided medical records and evaluation of the provided photographs of the devices.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show the trunnion of the stem is severely worn.Damage is consistent with loss of taper lock.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this product inquiry concerns a male patient who underwent a right total hip arthroplasty with a cobalt chrome femoral head with an accolade stem.The patient developed had neck disassociation with trunnionosis.I can confirm that the patient underwent both primary and revision surgeries since i was able to review the x-rays.I can also confirm that trunnionosis and trunnion deformity was present since i was able to see intraoperative photos displaying those findings.The root cause of this event cannot be determined with certainty.The causes of trunnionosis and head neck disassociation are multifactorial including surgical technique factors, especially in the preparation, or lack thereof, of the femoral head and trunnion prior to final insertion.Other factors include patient activity level and bmi as well as 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: it was reported that the patient was revised due to disassociation of the head from the stem.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

It was reported that the patient arrived in er with discomfort in hip.Component failure discovered upon xray.The head disassociated from the stem.

• 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: 17854888
• MDR Text Key: 324734836
• Report Number: 0002249697-2023-01093
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MKDPET
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male