MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LEFT HEMIPELVIS REPL SIZE H TRIDENT ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number C-M110-1-400

Device Problems Off-Label Use (1494); Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2019

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There has been 1 other similar event for the lot referenced.This was for the same device in the same patient for an intraoperative event.

Event Description

This pi is to address the second surgery (b)(6) 2019.Primary procedure, left custom heavy pelvis.It was reported that after implanting the replacement pelvis and two axsos screws, the surgeon noticed excessive bleeding and had to remove the devices to find the source.The surgeon decided to abort the procedure and closed the patient.Post-operatively, the patient is stable.The surgeon reported his belief that in removing scar tissue (patient diagnosed with ewings sarcoma and had a previous procedure to resect bone), he may have hit a vessel which caused the bleeding.Rep confirmed there are no allegations against the implants.Update (b)(6) 2019: hospital re-sterilized the implant and cut off parts to modify for the patient.The surgery was then completed successfully with no further information provided by the surgeon and hospital.

Manufacturer Narrative

An event regarding a revision involving left hemipelvis repl size h trident id was reported.Conclusion: an initial attempt to implant this device was made on (b)(6) 2019.It was reported that after implanting the replacement pelvis and two axsos screws, the surgeon noticed excessive bleeding and had to remove the devices to find the source.The surgeon decided to abort the procedure and closed the patient (pi (b)(4)).Post-operatively, the patient was stable.The surgeon reported his belief that in removing scar tissue (patient diagnosed with ewings sarcoma and had a previous procedure to resect bone), he may have hit a vessel which caused the bleeding.On (b)(6) 2019, the surgeon modified the implant, re-sterilized it and successfully implanted it on (b)(6) 2019.No further information was provided.Based on this provided information it has been determined that this event is associated with an off-label application.A review of the device manufacturing records indicated qin (b)(4), was packaged with the device at the time of manufacture.The router does not indicate the version of the package insert.A review of the most recent version of the document, rev aa, noted the following: sterilization these products have been sterilized by either gamma radiation or hydrogen peroxide.Refer to the package label for the sterilization method.If the package is opened, but the product is not used, the prosthesis must not be resterilized and must therefore be discarded or returned to the supplier.Single use devices cannot be explanted and subsequently reimplanted as the physical forces exerted by these actions may compromise the physical integrity, dimensions and/or surface finishes of the devices.Also, sterility cannot be assured for reused devices as cleaning and re-sterilization procedures have not been verified.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

This pi is to address the second surgery on (b)(6) 2019.Primary procedure, left custom heavy pelvis.It was reported that after implanting the replacement pelvis and two axsos screws, the surgeon noticed excessive bleeding and had to remove the devices to find the source.The surgeon decided to abort the procedure and closed the patient.Post-operatively, the patient is stable.The surgeon reported his belief that in removing scar tissue (patient diagnosed with ewings sarcoma and had a previous procedure to resect bone), he may have hit a vessel which caused the bleeding.Rep confirmed there are no allegations against the implants.Update 19/nov/2019: hospital re-sterilized the implant and cut off parts to modify for the patient.The surgery was then completed successfully with no further information provided by the surgeon and hospital.

• Brand Name: LEFT HEMIPELVIS REPL SIZE H TRIDENT ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9469465
• MDR Text Key: 176556459
• Report Number: 0002249697-2019-04025
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-M110-1-400
• Device Lot Number: 9K59PD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 143