MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+8MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-344
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	08/12/2021
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 has been reported "cone wear of the hip stem".Update 20aug21 - additional information from the surgeon: revision right hip tep via dorsal approach was performed on (b)(6) 2021.Analysis of the joint: metalosis, cone of the hip stem used up, pe inlay damaged, cup.Trident x3 /58mm fixed, head cocr 44mm/v40cone.Removal of the hip stem via transfemoral approach.The cone of the femoral stem was used up.The femoral head is luxated.
Event or Problem Description
It has been reported "cone wear of the hip stem." update 20aug21 - additional information from the surgeon: revision right hip tep via dorsal approach was performed on (b)(6) 2021.Analysis of the joint: metalosis, cone of the hip stem used up, pe inlay damaged, cup trident x3 /58mm fixed, head cocr 44mm/v40cone.Removal of the hip stem via transfemoral approach.The cone of the femoral stem was used up.The femoral head is luxated."head disassociation from the femoral stem.".
Additional Manufacturer Narrative
Reported event an event regarding disassociation and wear involving an unknown head was reported.The event was confirmed via clinician review.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 information by a clinical consultant indicated: this inquiry reports the revision of a total hip replacement due to head disassociation from the femoral stem with evidence of trunnion deformity and wear.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnion deformity and wear are multifactorial including implant factors, surgical technique factors and patient factors.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to head disassociation from the femoral stem with evidence of trunnion deformity and wear.The event was confirmed via clinician review.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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It has been reported "cone wear of the hip stem" update 20aug21 - additional information from the surgeon: -revision right hip tep via dorsal approach was performed on (b)(6) 2021.-analysis of the joint: metalosis, cone of the hip stem used up, pe inlay damaged, cup trident x3 /58mm fixed, head cocr 44mm/v40cone.- removal of the hip stem via transfemoral approach.- the cone of the femoral stem was used up.- the femoral head is luxated."head disassociation from the femoral stem.".
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear/metallosis involving a metal head was reported.The disassociation event was confirmed by clinician review of provided medical records.The wear/metallosis 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.-clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the revision of a total hip replacement due to head disassociation from the femoral stem with evidence of trunnion deformity and wear.I can confirm that this event took place since i was able since i was able to see the implant removed.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnion deformity and wear are multifactorial including implant factors, surgical technique factors and patient factors.-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: the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

• Brand Name: V40 COCR LFIT HEAD 44MM/+8MM
• 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: 12432514
• Report Number: 0002249697-2021-01504
• Device Sequence Number: 11638812
• Product Code: JDI
• UDI-Device Identifier: 07613327032802
• UDI-Public: 07613327032802
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2022

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: 12/31/2014
• Device Model Number: 6260-9-344
• Device Catalogue Number: 6260-9-344
• Device Lot Number: MHRMTL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 01/11/2022; 06/02/2022
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 02/01/2022; 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2009
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male