MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-132
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Reaction (2414); Metal Related Pathology (4530)
Date of Event	01/28/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding abnormal ion levels involving an unknown metal head was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation - the device remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device identification and return, x-rays, operative reports, pathology as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
On or about (b)(6) 2014, a registered nurse tripped and fell at the hospital landing on her right hip.As a result of the accident, she fractured her right hip and required her to undergo a total hip replacement surgery on (b)(6) 2014 where she had a stryker lfit v40 head implanted into her body.On (b)(6) 2017 plaintiffs orthopedic surgeon advised patient of the elevated levels of cobalt and chromium in her bloodwork.Patients right hip has not yet been revised.
Event or Problem Description
On or about (b)(6) 2014, a registered nurse tripped and fell at the hospital landing on her right hip.As a result of the accident, she fractured her right hip and required her to undergo a total hip replacement surgery on (b)(6) 2014 where she had a stryker lfit v40 head implanted into her body.On (b)(6) 2017 plaintiffs orthopedic surgeon advised patient of the elevated levels of cobalt and chromium in her bloodwork.
Additional Manufacturer Narrative
Corrected data: manufacturing site for devices.An event regarding altr involving a metal head was reported.The event was confirmed via clinician review of the provided medical records.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 records by a clinical consultant indicated: "this inquiry concerns a female patient who underwent a primary total hip arthroplasty with an accolade implant and in lfit femoral head and then subsequently almost 6 years later underwent revision surgery for femoral loosening and trunnionosis with pseudo-tumor.I can confirm that the patient underwent the primary procedure and the revision procedure since i was able to review the operation reports.The root cause of this type of failure with pseudo-tumor formation and trunnionosis as well as femoral loosening cannot be determined with certainty.The causes of trunnionosis, pseudo-tumor formation and femoral loosening are multifactorial including surgical technique, especially in the preparation for implantation of the femoral component and trunnion and femoral head, patient factors such as bmi and activity level, 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: this inquiry concerns a female patient who underwent a primary total hip arthroplasty with an accolade implant and in lfit femoral head and then subsequently almost 6 years later underwent revision surgery for femoral loosening and trunnionosis with pseudo-tumor.I can confirm that the patient underwent the primary procedure and the revision procedure since i was able to review the operation reports.The root cause of this type of failure with pseudo-tumor formation and trunnionosis as well as femoral loosening cannot be determined with certainty.The causes of trunnionosis, pseudo-tumor formation and femoral loosening are multifactorial including surgical technique, especially in the preparation for implantation of the femoral component and trunnion and femoral head, patient factors such as bmi and activity level, as well as 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: 32MM STD LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8327815
• Report Number: 0002249697-2019-00951
• Device Sequence Number: 16556634
• Product Code: JDI
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K010757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 6260-9-132
• Device Lot Number: 45453002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female