MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 1236-2-854

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348); Reaction (2414)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding infection involving an adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show recently explanted devices; an mdm liner and adm liner and a ceramic head (competitor device).There is blood and what appears to be biological matter on the explanted components.The ceramic head remains in the adm liner.There is nothing else remarkable to report.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicate 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 lot or sterile lot referenced.Conclusions: the event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports, pathology reports including the strain of infection identified as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported: [surgeon] removed mdm liner and insert from patient.Replaced with a stryker trident x3 10° poly insert".Spoke to rep.Patient was revised due to suspected infection and suspected metallosis (infection and metallosis suspicions reported by surgeon, unknown if clinically confirmed/ identified).Rep provided explant pictures showing the mdm/ adm liner construct and competitor ceramic head explanted (rep confirmed the head was a competitor head).

• Brand Name: RESTORATION ADM X3 INS 28/54
• 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: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 8266674
• MDR Text Key: 133712253
• Report Number: 0002249697-2019-00242
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540639004
• UDI-Public: 04546540639004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 1236-2-854
• Device Lot Number: 322126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• 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: 77 YR
• Patient Weight: 75