MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-848

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Ambulation Difficulties (2544); Cancer (3262)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: primary tritanium hemi cluster hole cup 56mm; cat#502-03-56e; lot#ad3d99; modular dual mobility insert; cat#626-00-42e; lot#54060303; delta v-40 ceramic head 28/-2,7; cat#6570-0-328; lot#51274602; size 5 accolade ii 127 deg; cat#6721-0535; lot#55265509; 6.5 cancellous bone screw 25mm; cat#2030-6525-1; lot#851y9l; 6.5 cancellous bone screw 25mm; cat#2030-6525-1; lot#6d6603.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

The patient has a history of femoral metastatic osteosarcoma of the left leg and failed total knee arthroplasty which required a tumor resection, total femoral replacement and revision to his tha.Patient reported difficulty bearing weight on left leg on (b)(6) 2019 and was diagnosed with a left femur lytic lesion.

Manufacturer Narrative

An event regarding revision involving an adm liner was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Clinician review: the available medical records were provided to a consulting clinician for a review which noted that - "older gentleman with a complex history including metastatic osteosarcoma underwent a left tka in 2004 which in 2006 became infected with mrsa requiring explantation,iv antibiotics and subsequent reimplantation.In 2016 he underwent an index left tha.In (b)(6) 2019 he developed pain in his left femur and was found to a lytic lesion.The lesion was biopsied and found to be metastatic undifferentiated osteosarcoma.He was started on neoadjuvant chemotherapy and then underwent radical resection of his left femur with explantatation of both his tha and revision tka with implantation of atotal femur implant including tha and tka.Review of these records confirms the patients tha and tka were revised to a total femoral implant with tha and tka.This was necessitated by a lytic metastatic osteosarcoma lesion in his femur located between the tips if his tha stem and revision tka stem.- device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.- complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient had pain and was revised due to difficulty in bearing weight on left leg and was diagnosed with a left femur lytic lesion.The available medical records were provided to the consulting clinician for a review which concluded that the review of these records confirms the patients tha and tka were revised to a total femoral implant with tha and tka.This was necessitated by a lytic metastatic osteosarcoma lesion in his femur located between the tips if his tha stem and revision tka stem.The exact cause of the event could not be determined because insufficient information was available with stryker.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The patient has a history of femoral metastatic osteosarcoma of the left leg and failed total knee arthroplasty which required a tumor resection, total femoral replacement and revision to his tha.Patient reported difficulty bearing weight on left leg on (b)(6) 2019 and was diagnosed with a left femur lytic lesion.

• Brand Name: RESTORATION ADM X3 INS 28/48
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8981140
• MDR Text Key: 161075497
• Report Number: 0002249697-2019-03154
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638977
• UDI-Public: 04546540638977
• Combination Product (y/n): N
• PMA/PMN Number: K093644
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 1236-2-848
• Device Lot Number: 53794901
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 111