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 Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	10/07/2019
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.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a 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 analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.
Event or Problem Description
Patients hip was revised for infection.Upon extraction of the accolade tmzf hip stem and v40 lfit head, corrosion was noted around the stem trunnion.
Additional Manufacturer Narrative
An event regarding infection and corrosion involving a lfit v40 cocr head that was mated with an accolade stem.The infection event was not confirmed; however the corrosion event was confirmed.Method & results: device evaluation and results: visual inspection visual inspection was performed as part of the material analysis report (mar), dated 12-nov-2019.This inspection indicated damage consistent with the stem trunnion and head taper interaction was observed on the inner taper of the head.Debris was observed on the taper of the head; this debris was collected on an sem (scanning electron microscope) stub for further analysis.Material analysis a material analysis has been performed.The report concluded damage on the inner taper of the head was consistent with stem trunnion / taper interaction.Xrf showed the stem and head base alloys were consistent with their respective drawings.Eds showed that the debris from the head and stem were both consistent with an oxide, a corrosion product, biological material, and the stem base material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional and functional inspection not performed as these aspects are not in question.Clinician review: a review of the provided medical records by a clinical consultant stated they "cannot confirm event, need additional information; revision operative report, clinical and past medical history, additional serial dated x-rays and examination of explanted components.¿ device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar events for lot or sterile lot referenced.Conclusion: a review of the provided medical records by a clinical consultant stated they "cannot confirm event, need additional information; revision operative report, clinical and past medical history, additional serial dated x-rays and examination of explanted components.¿ all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, revision operative report, clinical and past medical history, additional serial dated x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Patients hip was revised for infection.Upon extraction of the accolade tmzf hip stem and v40 lfit head, corrosion was noted around the stem trunnion.

• 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
• MDR Report Key: 9261692
• Report Number: 0002249697-2019-03660
• Device Sequence Number: 3671524
• Product Code: LPH
• UDI-Device Identifier: 07613327032765
• UDI-Public: 07613327032765
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 08/31/2013
• Device Model Number: 6260-9-340
• Device Catalogue Number: 6260-9-340
• Device Lot Number: LY4MLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: 68 YR
• Patient Weight: 78