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	Corroded (1131); Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level involving an unknown metal head was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device 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.  conclusion: the event could not be determined because insufficient information was provided.Further information such as device identification and return, pre- and post-operative x-rays, 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 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 right hip on or about (b)(6) 2008 and was revised on (b)(6) 2019.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 abnormal ion level/metallosis involving a metal head was reported.The abnormal ion level/metallosis 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: 'relevant clinical history and timelines: this product inquiry concerns a male patient who underwent a primary cementless right total hip arthroplasty on (b)(6) 2018, with a 32 mm standard lfit femoral head and an accolade tmzf hip stem.Patient subsequently developed trunnionosis with elevated cobalt levels and pain.Patient required revision surgery which was carried out on (b)(6) 2019.Findings at surgery confirmed corrosion around the trunnion and inside the femoral head.There was no loss of volume of the trunnion so it was decided to retain the stem.The patient was revised with a new polyethylene liner and a ceramic head over an adapter sleeve on the retained trunnion.Conclusion of assessment: this case concerns a 78-year-old gentleman who underwent revision of his left total hip arthroplasty approximately 11 years after implantation for pain, trunnionosis and elevated metal ion levels.I can confirm that the patient underwent the primary procedure since i was able to see the original stryker stickers.I can confirm that patient underwent the revision procedure because i was able to review the revision operation report.The root cause of trunnionosis and elevated metal ions cannot be determined with absolute certainty.The causes are multifactorial including surgical technique, patient factors including activity level, lifestyle and bmi, as well as possible implant factors.The explanted devices should be submitted stryker engineers for metallurgical analysis and examination to determine if any material defects were present.Device 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 was revised due to metallosis/elevated metal ions.A review of the provided medical records by a clinical consultant indicated the following: "relevant clinical history and timelines: this product inquiry concerns a male patient who underwent a primary cementless right total hip arthroplasty on (b)(6) 2008, with a 32 mm standard lfit femoral head and an accolade tmzf hip stem.Patient subsequently developed trunnionosis with elevated cobalt levels and pain.Patient required revision surgery which was carried out on (b)(6) 2019.Findings at surgery confirmed corrosion around the trunnion and inside the femoral head.There was no loss of volume of the trunnion so it was decided to retain the stem.The patient was revised with a new polyethylene liner and a ceramic head over an adapter sleeve on the retained trunnion.Conclusion of assessment: this case concerns a 78-year-old gentleman who underwent revision of his left total hip arthroplasty approximately 11 years after implantation for pain, trunnionosis and elevated metal ion levels.I can confirm that the patient underwent the primary procedure since i was able to see the original stryker stickers.I can confirm that patient underwent the revision procedure because i was able to review the revision operation report.The root cause of trunnionosis and elevated metal ions cannot be determined with absolute certainty.The causes are multifactorial including surgical technique, patient factors including activity level, lifestyle and bmi, as well as possible implant factors.The explanted devices should be submitted stryker engineers for metallurgical analysis and examination to determine if any material defects were present." 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 his right hip on or about (b)(6) 2008 and was revised on (b)(6) 2019.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.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11810931
• Report Number: 0002249697-2021-00833
• Device Sequence Number: 14243298
• Product Code: JDI
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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 Catalogue Number: 6260-9-132
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 78 YR
• Patient Sex: Male