MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-240
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214)
Health Effect - Clinical Codes	Fall (1848); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	07/26/2022
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 his left hip on or about (b)(6), 2015 and was revised on (b)(6), 2022.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.
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) 2015 and was revised on (b)(6) 2022.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 corrosion, abnormal ion level involving a metal head was reported.The event of corrosion was confirmed.Abnormal ion level was not confirmed.Method & results: product evaluation and results: material, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: conclusion/assessment: a patient underwent a tha with a v40 cocr head 40mm and an accolade ii stem.Approximately 71/2 years later the patient underwent a revision for pain after having a fall and mri showing tearing of the abductors, a fluid collection, osteolysis.The preop laboratory studies did not show infection but had reported increase in co level (normal levels not provided).At the time of the revision there were signs of trunnionosis and metallosis.The pre and postoperative medical records, radiographs, and laboratory reports were not provided for review.Event confirmation: a revision surgery can be confirmed.Metalloisis and presumed trunnionosis can be confirmed.Increased metal levels were reported in the operative note, but the laboratory reports not provided.Device recall and injury cannot be confirmed.Root cause: the root cause of the revision surgery was pain after a fall, fracture of the trochanter, and what appeared to be trunnionosis with soft tissue metal response.The root cause of the trunnionois cannot be determined.The root cause of the other allegations cannot be determined as they cannot be confirmed.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 the provided medical information by a clinical consultant indicated: conclusion/assessment: a patient underwent a tha with a v40 cocr head 40mm and an accolade ii stem.Approximately 71/2 years later the patient underwent a revision for pain after having a fall and mri showing tearing of the abductors, a fluid collection, osteolysis.The preop laboratory studies did not show infection but had reported increase in co level (normal levels not provided).At the time of the revision there were signs of trunnionosis and metallosis.The pre and postoperative medical records, radiographs, and laboratory reports were not provided for review.Event confirmation: a revision surgery can be confirmed.Metalloisis and presumed trunnionosis can be confirmed.Increased metal levels were reported in the operative note, but the laboratory reports not provided.Device recall and injury cannot be confirmed.Root cause: the root cause of the revision surgery was pain after a fall, fracture of the trochanter, and what appeared to be trunnionosis with soft tissue metal response.The root cause of the trunnionois cannot be determined.The root cause of the other allegations cannot be determined as they cannot be confirmed.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.

• Brand Name: V40 COCR LFIT HEAD 40MM/+4
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15534773
• Report Number: 0002249697-2022-01429
• Device Sequence Number: 7848310
• Product Code: JDI
• UDI-Device Identifier: 07613327032741
• UDI-Public: 07613327032741
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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: 04/30/2018
• Device Catalogue Number: 6260-9-240
• Device Lot Number: MME39E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Male