MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6260-9-140

Device Problems Contamination (1120); Insufficient Information (3190)

Patient Problem Metal Related Pathology (4530)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving an unknown metal head was reported.The event was not confirmed.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: no medical records were received for review with a clinical consultant.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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2015 and was revised on (b)(6) 2020.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lift anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2015 and was revised on (b)(6), 2020.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.

Manufacturer Narrative

Reported event an event regarding altr involving a metal head was reported.The event was not confirmed.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: conclusion of assessment: this inquiry reports the failure of an open reduction and internal fixation of a fracture of the proximal femur which was then internally fixed and a hip arthroplasty was carried out.About five years later construct failed due to what is reported as an adverse local soft tissue reaction and a revision was carried out with a constrained liner.I can confirm that revision took place since i was able to review both operation reports but i have had no x-rays to review which would be helpful.I cannot confirm that failure was due to metallosis or adverse local soft tissue reaction or elevated metal ion levels because i have no corroborating evidence.Regarding the possible root cause of this event, i cannot determine it with certainty.Failure of total hip arthroplasty following failure of internal fixation is multifactorial.After conversion to total hip replacement, failure is also multifactorial.These causes include surgical technique factors, patient factors and possibly implant factors.-product history review: review of the device history records indicate the 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 exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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: V40 COCR LFIT HEAD 40MM/+0
• 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: 12127493
• MDR Text Key: 260231260
• Report Number: 0002249697-2021-01148
• Device Sequence Number: 1
• Product Code: JDI
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 6260-9-140
• Device Lot Number: MNRHVY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2015
• 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): Hospitalization; Required Intervention
• Patient Sex: Female