MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-850

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

The patient was revised due to possible dislocation.When the surgeon opened the joint, he found that the poly was rotated in the 28 mm internal head.The surgeon did not think that the construct was clinically dislocated.

Manufacturer Narrative

An event regarding dislocation involving an adm liner and femoral head was reported.The event was confirmed based on the x-rays provided.Method & results: product evaluation and results: not performed as no items were returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: i have seen the limited info for this patient with a suspected adm x3 liner dislocation, implanted in combination with an accolade stem.There are two identical x-rays to show the post event condition with an eccentric femoral head in the shell, probably in contact with the metal inside of the shell/liner, to suggest an intraprosthetic dislocation.During revision, the surgeon observed an upside down tilt of the adm poly cap over the femoral head.Not quite a dislocation possibly where it could theoretically be possible that this tilted poly cap was still around the femoral head although in a quite unphysiological position with impossible kinematics without chance on spontaneous improvement.So, revision surgery was certainly indicated although it was not reported what actually was done during revision surgery for patient privacy reasons.The cup shell has an adequate position regarding inclination and probably also anteversion although no lateral x-ray is available for cross check of anteversion.Because there is no other clinical information available and no explants were returned for investigation, root cause of failure remains unknown.This case needs more information to solve.-product history review: all 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 reported lot.The exact cause of the event could not be determined because further information such as device evaluation, further 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 as no devices were returned and 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 was revised due to possible dislocation.When the surgeon opened the joint, he found that the poly was rotated in the 28mm internal head.The surgeon did not think that the construct was clinically dislocated.

• Brand Name: RESTORATION ADM X3 INS 28/50
• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7096652
• MDR Text Key: 94138630
• Report Number: 0002249697-2017-03512
• Device Sequence Number: 1
• Product Code: MEH
• 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,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 1236-2-850
• Device Lot Number: 49913501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 62