MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-440
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Reported event: 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 the item was not returned.Clinician review: not performed because no medical records or x-rays were made available for evaluation.Product history review: a review of the product history records could not be performed as the device was not properly identified.Complaint history review: a complaint history review could not be performed as the device was not properly identified.Conclusions: it was reported that the patient had elevated blood ion levels.The event could not be confirmed, nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as medical documentation and returned devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem 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) 2009, and was revised on (b)(6) 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in her blood.
Additional Manufacturer Narrative
Reported event: an event regarding wear and abnormal ion level involving a metal head was reported.The wear event was confirmed via clinician review of the provided medical records.Abnormal ion level was not confirmed.Method and results: product evaluation and results: visual inspection, 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 female patient underwent an initial index total hip arthroplasty which was cemented and failed.She then underwent a revision for loosening of the components.She subsequently about 10 years later underwent another revision for trunnionosis.I can confirm that the patient had a revision procedure for loosening of the components in 2009 since i was able to review the operation report.I can also confirm the revision for trunnionosis in 2019 because i was able to see the operation report.The root cause of these events cannot be determined with certainty.The causes of loosening of components and subsequent trunnionosis of a revision prosthesis are multifactorial.These factors include surgical technique factors such as cement technique and local bone factors including patient factors such as activity level and bmi.It would be unusual to implicate the implant in a case of routine loosening.Regarding trunnionosis, the causes are also multifactorial including surgical technique factors especially preparation of the trunnion and insertion technique of the femoral head on the trunnion, as well as patient factors such as activity level and bmi and implant factors.The explanted prostheses should be submitted to stryker engineers for metallurgical analysis and examination.It is difficult to assess the effect of using a competitor acetabular component with a stryker femoral component and femoral head but this could factor into the event.Also, the cone body sticker should be further examined to see if there was an incompatibility regarding the offset of the femoral head." 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: the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall ra 2016-028 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 or Problem 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) 2009 and was revised on (b)(6) 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in her blood.Update: 11/07/2023: in addition to trunnionosis, per med review "operative findings revealed evidence of corrosion around the head with black metal impregnation of the soft tissues.".

• Brand Name: V40 COCR LFIT HEAD 40MM/+12
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11573557
• Report Number: 0002249697-2021-00539
• Device Sequence Number: 3622332
• Product Code: JDI
• UDI-Device Identifier: 07613327032772
• UDI-Public: 07613327032772
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 6260-9-440
• Device Lot Number: MENMPD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2007
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female