MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_LFIT V40 COCR FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_JR

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

Patient Problems Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 04/03/2023

Event Type  Injury  

Event Description

Patient has an accolade tmzf stem in with a large cocr lfit metal femoral head( 36 or 40) and trunion neck of stem is fully corroded down to a pencil tip.A ton of metallosis.Was done years ago, but not sure of when or where."left side hip.".

Manufacturer Narrative

Reported event: an event regarding disassociation and wear(metallosis) involving an unknown metal head was reported.The event of disassociation was confirmed via review of the provided medical records by a clinical consultant.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 of the provided medical information by a clinical consultant indicated: "this patient underwent a primary cementless total hip arthroplasty at some point in the past and developed had neck disassociation due to trunnionosis and developed metallosis.Explantation of the prosthesis was carried out.I can confirm that the patient had a primary hip arthroplasty and suffered head neck disassociation with trunnion deformity since i saw the xrays.I cannot confirm the metallosis nor the type of revision procedure or construct.I cannot determine the root cause of this event with certainty.The causes of head neck disassociation with trunnionosis and metallosis are multifactorial including surgical technique factors, patient activity level and bmi, and implant factors." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to disassociation of the head from the stem.Metallosis was observed.The event of disassociation was confirmed via review of the provided medical records by a clinical consultant which indicated the following: "this patient underwent a primary cementless total hip arthroplasty at some point in the past and developed had neck disassociation due to trunnionosis and developed metallosis.Explantation of the prosthesis was carried out.I can confirm that the patient had a primary hip arthroplasty and suffered head neck disassociation with trunnion deformity since i saw the xrays.I cannot confirm the metallosis nor the type of revision procedure or construct.I cannot determine the root cause of this event with certainty.The causes of head neck disassociation with trunnionosis and metallosis are multifactorial including surgical technique factors, patient activity level and bmi, and implant factors." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient has an accolade tmzf stem in with a large cocr lfit metal femoral head( 36 or 40) and trunion neck of stem is fully corroded down to a pencil tip.A ton of metallosis.Was done years ago, but not sure of when or where."left side hip".

Manufacturer Narrative

Reported event: an event regarding disassociation and wear(metallosis) involving an unknown metal head was reported.The event of disassociation was confirmed via review of the provided medical records by a clinical consultant.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 of the provided medical information by a clinical consultant indicated: "this patient underwent a primary cementless total hip arthroplasty at some point in the past and developed had neck disassociation due to trunnionosis and developed metallosis.Explantation of the prosthesis was carried out.I can confirm that the patient had a primary hip arthroplasty and suffered head neck disassociation with trunnion deformity since i saw the x-rays.I cannot confirm the metallosis nor the type of revision procedure or construct.I cannot determine the root cause of this event with certainty.The causes of head neck disassociation with trunnionosis and metallosis are multifactorial including surgical technique factors, patient activity level and bmi, and implant factors." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to disassociation of the head from the stem.Metallosis was observed.The event of disassociation was confirmed via review of the provided medical records by a clinical consultant which indicated the following: "this patient underwent a primary cementless total hip arthroplasty at some point in the past and developed had neck disassociation due to trunnionosis and developed metallosis.Explantation of the prosthesis was carried out.I can confirm that the patient had a primary hip arthroplasty and suffered head neck disassociation with trunnion deformity since i saw the x-rays.I cannot confirm the metallosis nor the type of revision procedure or construct.I cannot determine the root cause of this event with certainty.The causes of head neck disassociation with trunnionosis and metallosis are multifactorial including surgical technique factors, patient activity level and bmi, and implant factors." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN_LFIT V40 COCR FEMORAL HEAD
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16830300
• MDR Text Key: 314160062
• Report Number: 0002249697-2023-00440
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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 Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 81 YR
• Patient Sex: Female