MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number 1236-2-852

Device Problem Degraded (1153)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding revision surgery involving an adm liner was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection: the reported device was not returned; however, photographs were provided for review.As per a review of the photographs by a clinician {.} the explanted adm bearing and femoral head have no obvious pathology, at least no visible corrosion on the macroscopic explant view.{.} material analysis, 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-rays by a clinical consultant indicated: cup malposition has contributed to impingement between stem neck and cup rim causing stem neck damage with osteolysis around both stem and cup with periprosthetic fracture in the proximal femur requiring revision surgery with fracture stabilization.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 exact cause of the event could not be determined because insufficient information was provided.Additional information including lot details and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

The case was booked as a head and liner exchange.When the head was removed the surgeon decided the trunnion had damage and decided to remove the stem.Update: as per clinician review, cup malposition has contributed to impingement between stem neck and cup rim causing stem neck damage with osteolysis around both stem and cup with periprosthetic fracture in the proximal femur requiring revision surgery with fracture stabilization.

• Brand Name: RESTORATION ADM X3 INS 28/52
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8228825
• MDR Text Key: 132442271
• Report Number: 0002249697-2019-00102
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 04546540638991
• UDI-Public: 04546540638991
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1236-2-852
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• 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): Hospitalization; Required Intervention