MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SHELL; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding disassociation involving an unknown accolade stem and head was reported.The disassociation and stem malposition was confirmed through a medical review.The medical review also confirmed cup malposition.Device evaluation and results:material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.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.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.

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.Rep provided an x-ray and explant pictures and reported that additional x-rays, medical records, and further information are not available.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.

• Brand Name: UNKNOWN SHELL
• Type of Device: HIP IMPLANT
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8152438
• MDR Text Key: 129968314
• Report Number: 0002249697-2018-03977
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 87 YR