MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXPANDABLE PROXIMAL FEMUR 90MM REPLACEMENT; PROXIMAL FEMUR CUSTOM GROWING IMPLANT

Catalog Number C-M100-4-100

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

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 returned.

Event Description

This pi is for the revision of the patient's right hip on (b)(6) 2018.Having provided a stanmore patient specific prescription form for the patient's right proximal femur (pi 2476191), previous pin 21128 was indicated.Records for that pin show that the patient was being revised due to a loose distal stem, mentioning a conference call on 03/november/2017.To determine what was in situ, a report of a previous failed lengthening in (b)(6) 2017 (pi 1643991) was found indicating the patient had a stryker hip including a stryker custom growing device in situ.The stryker custom growing prosthesis, femoral head, and liner were revised to a stanmore jts construct and another stryker liner.

Event Description

This pi is for the revision of the patient's right hip on (b)(6) 2018.Having provided a stanmore patient specific prescription form for the patient's right proximal femur, previous pin 21128 was indicated.Records for that pin show that the patient was being revised due to a loose distal stem, mentioning a conference call on (b)(6) 2017.To determine what was in situ, a report of a previous failed lengthening in (b)(6) 2017 ((b)(4)) was found indicating the patient had a stryker hip including a stryker custom growing device in situ.The stryker custom growing prosthesis, femoral head, and liner were revised to a stanmore jts construct and another stryker liner.

Manufacturer Narrative

Reported event: an event regarding a loosening involving a expandable proximal femur 90mm replacement was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which was rejected stating, "no clinical or pmh, no operative reports, no serial x-rays, no examination of explanted components.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.".Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusion: it was reported that patient was revised due to loosening.The available medical records were provided to the consulting clinician for a review which was rejected stating that no clinical or pmh, no operative reports, no serial x-rays, no examination of explanted components.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.The event could not be confirmed nor the exact cause be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays 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.H3 other text : device not available.

• Brand Name: EXPANDABLE PROXIMAL FEMUR 90MM REPLACEMENT
• Type of Device: PROXIMAL FEMUR CUSTOM GROWING IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10474437
• MDR Text Key: 205119198
• Report Number: 0002249697-2020-01768
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: C-M100-4-100
• Device Lot Number: K03A536
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR
• Patient Weight: 29