MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-128
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414); Metal Related Pathology (4530)
Date of Event	04/22/2013
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.Product not available.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit cocr v40 femoral head on his left hip on or about (b)(6) 2013.It is further alleged that he suffered injuries as a result of implantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Patient has not had the femoral head at issue explanted.
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinical review - a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a left hip bipolar hemi arthroplasty for a sub capital fracture since i was able to review the operation report.I can also confirm that the patient had a revision of that hip with conversion to a total hip replacement with replacement of the femoral stem as well since i was also able to review the operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of a slightly elevated cobalt level are difficult to determine.There was no mention of any problem with the trunnion and no mention of any soft tissue changes or pseudo-tumor or adverse local tissue reaction.The operation note for the revision stated that normal joint fluid was encountered and there was no damage to the trunnion.In fact there was no preoperative or postoperative diagnosis given for the revision.Based upon the information given, i could not assign any causality to the implant itself." -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: it was reported that the patient was revised due to excessive levels of chromium and cobalt in his blood.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a left hip bipolar hemi arthroplasty for a sub capital fracture since i was able to review the operation report.I can also confirm that the patient had a revision of that hip with conversion to a total hip replacement with replacement of the femoral stem as well since i was also able to review the operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of a slightly elevated cobalt level are difficult to determine.There was no mention of any problem with the trunnion and no mention of any soft tissue changes or pseudo-tumor or adverse local tissue reaction.The operation note for the revision stated that normal joint fluid was encountered and there was no damage to the trunnion.In fact there was no preoperative or postoperative diagnosis given for the revision.Based upon the information given, i could not assign any causality to the implant itself." 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 cocr v40 femoral head on his left hip on or about (b)(6), 2013.It is further alleged that he suffered injuries as a result of implantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.Patient has not had the femoral head at issue explanted.

• Brand Name: 28MM 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8395084
• Report Number: 0002249697-2019-01263
• Device Sequence Number: 14209731
• Product Code: JDI
• UDI-Device Identifier: 07613327013023
• UDI-Public: 07613327013023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: 06/30/2017
• Device Catalogue Number: 6260-9-128
• Device Lot Number: 40426801
• 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: 02/07/2019
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2012
• 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; Other; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male