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

Catalog Number 6260-9-036

Device Problems Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problems Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

On (b)(6) 2008 implantation of a stryker hip prosthesis with trident screw acetabular cup, pe inlay, accolade stem, metal head.In the course now increasing instability with multiple falls.On (b)(6) 2023 evidence of premature material wear.V.A implant fracture, revision surgery on (b)(6) 2023 with massive metallosis and evidence of complete wear of the metal femoral neck.

Event Description

On (b)(6) 2008 implantation of a stryker hip prosthesis with trident screw acetabular cup, pe inlay, accolade stem, metal head.In the course now increasing instability with multiple falls.On (b)(6) 2023 evidence of premature material wear.V.A implant fracture, revision surgery on (b)(6) 2023 with massive metallosis and evidence of complete wear of the metal femoral neck.

Manufacturer Narrative

An event regarding wear and disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted head with body fluids on it.It seemed to be removed still seated onto the trunnion of the stem.However, once removed from the stem in a second photo, there is evidence of wear of the trunnion, black tissue and the taper of the head appears dark in colour.Material analysis, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: 'this case concerns a patient who underwent a primary cementless total hip arthroplasty in 2008 and then approximately 18 years later developed head neck disassociation with metallosis requiring revision surgery.I can confirm that the patient underwent a primary total hip replacement and sustained a head neck disassociation since i was able to review x-rays showing the implants.I cannot confirm the revision surgery since i have no documentation such as office notes, operation note or post revision x-rays.The root causes of had neck disassociation with metallosis are multifactorial including surgical technique factors, trunnion and head preparation prior to implantation, patient factors such as activity level and bmi, and implant factors.The explanted femoral prosthesis and femoral head should be submitted to stryker engineers for examination and evaluation.' -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 has been one other similar event for the lot referenced for wear.Conclusions: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted head with body fluids on it.It seemed to be removed still seated onto the trunnion of the stem.However, once removed from the stem in a second photo, there is evidence of wear of the trunnion, black tissue and the taper of the head appears dark in colour.The subject device has been identified to be within scope of nc and capa.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.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17306632
• MDR Text Key: 319029129
• Report Number: 0002249697-2023-00767
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032291
• UDI-Public: 07613327032291
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 6260-9-036
• Device Lot Number: WL1MHE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2008
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 65 KG