MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +12 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-432
Medical Device Problem Codes	Material Erosion (1214); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414); Fluid Discharge (2686); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
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 his left hip on or about (b)(6) 2011 and the femoral head was explanted on (b)(6) 2018.It is further alleged that he 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 his blood.
Additional Manufacturer Narrative
Reported event: an event regarding altr involving a metal head was reported.The event was 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 medical records with a clinical consultant indicate " this case concerns a gentleman who underwent an index total hip arthroplasty in 2001, a revision arthroplasty in 2011 for recurrent instability and yet another revision in 2018 for elevated chromium and cobalt levels, trunnionosis and what appears to be pseudotumors.I cannot confirm the index surgery in 2001 since i only have documentation of this in a surgical operation report.I can confirm that the patient had a revision using a constrained liner with a +12 femoral head in 2011.I can also confirm that the patient underwent another revision in 2018 for elevated chromium and cobalt levels and trunnionosis.The root cause of recurrent instability is multifactorial and cannot be determined with certainty.Contributing factors include surgical technique factors including improper positioning of the implants, failure to restore the proper soft tissue tension in the thigh and possible impingement issues.Patient activity level and lifestyle, as well as bmi can also contribute.Instability can occur when there is stretching of the capsular tissues with loss of the normal periarticular constraints.Unless polyethylene wear was found or some other mechanical issue, i would not assign any causality to the implant itself for recurrent instability.The root causes of trunnionosis with elevated chromium and cobalt levels cannot be determined with certainty.Possible factors can be surgical technique including restoration of proper mechanics, and proper preparation of the trunnion before insertion of the femoral head.Along with the offset of the femoral implant, the use of a +12 mm neck length in my opinion can also possibly contribute to the development of corrosion but this has not been proven.Patient factors including activity level, lifestyle and bmi can also contribute.[.] -product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of medical records with a clinical consultant indicate "this case concerns a gentleman who underwent an index total hip arthroplasty in 2001, a revision arthroplasty in 2011 for recurrent instability, and yet another revision in 2018 for elevated chromium and cobalt levels, trunnionosis and what appears to be pseudotumors.I cannot confirm the index surgery in 2001 since i only have documentation of this in a surgical operation report.I can confirm that the patient had a revision using a constrained liner with a +12 femoral head in 2011.I can also confirm that the patient underwent another revision in 2018 for elevated chromium and cobalt levels and trunnionosis.The root cause of recurrent instability is multifactorial and cannot be determined with certainty.Contributing factors include surgical technique factors including improper positioning of the implants, failure to restore the proper soft tissue tension in the thigh and possible impingement issues.Patient activity level and lifestyle, as well as bmi can also contribute.Instability can occur when there is stretching of the capsular tissues with loss of the normal periarticular constraints.Unless polyethylene wear was found or some other mechanical issue, i would not assign any causality to the implant itself for recurrent instability.The root causes of trunnionosis with elevated chromium and cobalt levels cannot be determined with certainty.Possible factors can be surgical technique including restoration of proper mechanics, and proper preparation of the trunnion before insertion of the femoral head.Along with the offset of the femoral implant, the use of a +12 mm neck length in my opinion can also possibly contribute to the development of corrosion but this has not been proven.Patient factors including activity level, lifestyle and bmi can also contribute.[.]no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
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 his left hip on or about (b)(6) 2011 and the femoral head was explanted on (b)(6) 2018.It is further alleged that he 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 his blood.Update per op report: "there was a massive fluid collection that was dark red/brown color, watery in consistency.This was evacuated.There were multiple soft tissue necrotic masses throughout the joint.The biggest one measured approximately 10cm x 6cm.There were multiple smaller ones.Representative tissue samples were sent for frozen sections.This revealed no evidence of acute inflammation.The entire pericapsular tissue was necrotic.Debridement was quite extensive, requiring an extensive amount of time to find healthy-appearing tissue.".

• Brand Name: 32MM +12 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9652553
• Report Number: 0002249697-2020-00200
• Device Sequence Number: 11215113
• Product Code: JDI
• UDI-Device Identifier: 07613327013153
• UDI-Public: 07613327013153
• 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: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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: 02/28/2013
• Device Catalogue Number: 6260-9-432
• Device Lot Number: 25678002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2008
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male