MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE I STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Degraded (1153); Malposition of Device (2616); Material Deformation (2976); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

Device code reflected as per received explant pictures show degradation/deformation of the stem trunnion.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

It was reported that patient's right hip was revised due to disassociation of the head from the stem.Rep was not made aware of any patient complaints or intra-operative or pathological findings.

Event Description

It was reported that patient's right hip was revised due to disassociation of the head from the stem.Rep was not made aware of any patient complaints or intra-operative or pathological findings.Clinician review concluded: cup malposition in absent anteversion in combination with stem valgus malposition has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision.

Manufacturer Narrative

An event regarding disassociation involving an unknown accolade stem was reported.The disassociation and stem malposition was confirmed through a medical review.Altr was not confirmed.Device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted accolade stem.As per the medical review, a review of the photograph of the explanted stem identified the following; {.} explant photographs document severe metal substance loss from the accolade stem with some typical ¿pencil-shape¿ deformity of the trunnion.The accolade stem has adherent bone as sign of solid bone ingrowth ;ixation but the bone has some dark staining by metallic debris.{.} -medical records received and evaluation: a review of the provided x-ray by a clinical consultant indicated: {.} cup malposition in absent anteversion in combination with stem valgus malposition has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision.{.} -device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the investigation concluded {.} cup malposition in absent anteversion in combination with stem valgus malposition has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision.{.} if additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN ACCOLADE I STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7890980
• MDR Text Key: 120823549
• Report Number: 0002249697-2018-02973
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR