MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-332
Medical Device Problem Codes	Corroded (1131); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414); Insufficient Information (4580)
Date of Event	03/20/2019
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.
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) 2010 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 at issue, device recall and excessive levels of chromium and cobalt in her blood.
Additional Manufacturer Narrative
An event regarding excessive cobalt and chromium level involving an unknown lfit anatomic cocr v40 femoral head  was reported.The event was not confirmed.Method & results: product evaluation and results: device evaluation could not be performed as no items were returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusions it was reported that the patient had excessive levels of chromium and cobalt in her blood.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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) 2010 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 at issue, device recall and excessive levels of chromium and cobalt in her blood.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion involving a metal head was reported.The event was confirmed via clinician review.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 indicated "this case concerns a female patient who underwent resection of a cartilage tumor in the femoral neck on (b)(6) 2006.This was performed using a bipolar implant.The patient subsequently had revision for pain and acetabular wear on (b)(6) 2010.The patient developed aseptic loosening of the revision right total hip arthroplasty and underwent re-revision on (b)(6) 2019.At the time of surgery it was found that there was some evidence of corrosion seen on the trunnion.The root cause of these events cannot be determined with certainty.Regarding the revision for pain and wear of the acetabulum, this is a common occurrence following bipolar reconstruction.Symptoms occur because there has been no replacement of the acetabulum and the metal component wears down the acetabular cartilage causing pain.The root cause of a painful hip due to aseptic loosening is multifactorial including surgical technique factors in the way of proper preparation, fit, position and sizing as well as patient factors including activity level and bmi as well as local metabolic factors.The explanted prosthesis should be submitted to stryker engineers for evaluation and examination.In the absence of any defects, i would not assign any causality to the implant itself.The causes of corrosion surrounding a trunnion are multifactorial including surgical technique factors such as proper preparation of the trunnion and femoral head for implantation, patient factors such as activity level and bmi, and 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: a review of medical records with a clinical consultant indicated "this case concerns a female patient who underwent resection of a cartilage tumor in the femoral neck on (b)(6) 2006.This was performed using a bipolar implant.The patient subsequently had revision for pain and acetabular wear on (b)(6) 2010.The patient developed aseptic loosening of the revision right total hip arthroplasty and underwent re-revision on (b)(6) 2019.At the time of surgery it was found that there was some evidence of corrosion seen on the trunnion.The root cause of these events cannot be determined with certainty.Regarding the revision for pain and wear of the acetabulum, this is a common occurrence following bipolar reconstruction.Symptoms occur because there has been no replacement of the acetabulum and the metal component wears down the acetabular cartilage causing pain.The root cause of a painful hip due to aseptic loosening is multifactorial including surgical technique factors in the way of proper preparation, fit, position and sizing as well as patient factors including activity level and bmi as well as local metabolic factors.The explanted prosthesis should be submitted to stryker engineers for evaluation and examination.In the absence of any defects, i would not assign any causality to the implant itself.The causes of corrosion surrounding a trunnion are multifactorial including surgical technique factors such as proper preparation of the trunnion and femoral head for implantation, patient factors such as 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 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) 2010 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 at issue, device recall and excessive levels of chromium and cobalt in her blood.Update per medical records received from legal 02-oct-2023: patient was revised due to aseptic loosening.

• Brand Name: 32MM +8 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10263941
• Report Number: 0002249697-2020-01415
• Device Sequence Number: 11479529
• Product Code: JDI
• UDI-Device Identifier: 07613327013122
• UDI-Public: 07613327013122
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2023

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: 08/30/2012
• Device Catalogue Number: 6260-9-332
• Device Lot Number: 23873001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/26/2020; 10/23/2023
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 09/21/2020; 11/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2007
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female