MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6260-9-340
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	01/22/2020
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 was revised on (b)(6) 2020.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/ abnormal ion level and wear/ metallosis involving a metal head was reported.The device failure mode, i.E.Abnormal ion level or wear, was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photo showed a recent explanted metal head with large amount of inflammatory tissue which was removed from patient.Nothing remarkable was noticed on the metal head.-clinician review: a review of the provided medical information by a clinical consultant indicated: following assessment the revision of an lfit v40 femoral head on (b)(6) 2020 is confirmed.Findings in the operative report for this surgery describe gross metallosis throughout the hip and a large amount of inflammatory tissue consistent with pseudotumor.There was no documentation provided allowing confirmation of elevated serum metal ions.The root cause of this issue can not be established with the documentation provided.-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's hip was revised due to excessive levels of chromium and cobalt in his blood, gross metallosis throughout the hip and a large amount of inflammatory tissue consistent with pseudotumor.It was reported that once the black tissue was removed the trunnion was inspected and no damage to the trunnion was identified.The stem and cup were well fixed.The exact cause of the event could not be determined.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 left hip on or about (b)(6), 2011 and was revised on (b)(6), 2020.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 on 05-may-2022 based on clinician review: "[.] following assessment the revision of an lfit v40 femoral head on (b)(6) 2020 is confirmed.Findings in the operative report for this surgery describe gross metallosis throughout the hip and a large amount of inflammatory tissue consistent with pseudotumor.[.] ".

• Brand Name: V40 COCR LFIT HEAD 40MM/+8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12301698
• Report Number: 0002249697-2021-01350
• Device Sequence Number: 3971007
• Product Code: JDI
• UDI-Device Identifier: 07613327032765
• UDI-Public: 07613327032765
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 08/31/2016
• Device Model Number: 6260-9-340
• Device Catalogue Number: 6260-9-340
• Device Lot Number: MKLVKT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2011
• 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: 64 YR
• Patient Sex: Male