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

Model Number	6260-9-040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
All device were removed due to armd.Please investigate trunnion.After screw was removed, trident shell could be removed manually.Please investigate if in-growth and on-growth was advanced and if there was any device issue.Surgeon would like to know if this device was subject to recall.
Event or Problem Description
All device were removed due to armd.Please investigate trunnion.After screw was removed, trident shell could be removed manually.Please investigate if in-growth and on-growth was advanced and if there was any device issue.Surgeon would like to know if this device was subject to recall.
Additional Manufacturer Narrative
Reported event: an event regarding altr involving a metal head was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has scratches on the outer surface consistent with attempted explantation.There also appears to be a small amount of black material in the inner diameter of the head.Material analysis: material analysis was performed on the returned device.The report concluded the following: visual, sem and eds analysis of the three returned implant devices determined that the components were made with alloys consistent with their respective drawings.Analysis found adhered biological material consistent with having been implanted and removed.No excessive wear from the taper lock loosening was seen.Eds showed the stem was consistent with astm f1813 alloy, the head consistent with astm f1537 alloy, the shell with astm f136 alloy and the adhered material was consistent with biological bone material.No material non-conformances, nor manufacturing defects were found.Clinician review: no medical records were received for review with a clinical consultant.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 armd.The devices were returned for evaluation.Material analysis was performed on the returned device.The report concluded the following: visual, sem and eds analysis of the three returned implant devices determined that the components were made with alloys consistent with their respective drawings.Analysis found adhered biological material consistent with having been implanted and removed.No excessive wear from the taper lock loosening was seen.Eds showed the stem was consistent with astm f1813 alloy, the head consistent with astm f1537 alloy, the shell with astm f136 alloy and the adhered material was consistent with biological bone material.No material non-conformances, nor manufacturing defects were found.The event is not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the 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 additional information becomes 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; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11640686
• Report Number: 0002249697-2021-00650
• Device Sequence Number: 3160491
• Product Code: JDI
• UDI-Device Identifier: 07613327032703
• UDI-Public: 07613327032703
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: 12/31/2016
• Device Model Number: 6260-9-040
• Device Catalogue Number: 6260-9-040
• Device Lot Number: MKP08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2011
• 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 Sex: Female
• Patient Weight: 63 KG