MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT

Catalog Number 61910002

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Cement bha case.When cement was injected and the stem was inserted, blood pressure dropped and the operation was discontinued.As an emergency procedure, a trial cup of stryker was put in the acetabulum and then sutured as it was.Because of the high possibility of embolism due to fat, at the doctor's discretion, the 26 mm head plus 4 mm head and the cup 46 mm remained inside the body.Update: due to that event, the operation was delayed about 1 hour.

Manufacturer Narrative

Updated the event description and the implant and explant date.Reported event: an event regarding patient factors involving a simplex cement mix was reported.The event was not confirmed.Method & results: -device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.-clinician review: the available medical records were provided to the consulting clinician for a review which was rejected for a report stating," undated x-ray: ap of pelvis cemented right bha nominal, left hip cemented stem with small trial head reduced into uncemented poly acetabular shell.No clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no current status of the patient.The single x-ray appears to confirm the event description, but no medical report is possible based upon the information available for review.-device history review: could not be performed as the device lot code was unknown.-complaint history review: could not be performed as the device lot code was unknown.Conclusions: it was reported that when cement was injected and the stem was inserted, blood pressure dropped and the operation was discontinued.As an emergency procedure, a trial cup of stryker was put in the acetabulum and then sutured as it was.The event of blood pressure drop could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.However a review of the available x-ray by the consulting clinician confirms the presence of trials inside the patient.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

Cement bha case.When cement was injected and the stem was inserted, blood pressure dropped and the operation was discontinued.As an emergency procedure, a trial cup of stryker was put in the acetabulum and then sutured as it was.Because of the high possibility of embolism due to fat, at the doctor's discretion, the 26 mm head plus 4 mm head and the cup 46 mm remained inside the body.Update: due to that event, the operation was delayed about 1 hour.Update: "the product was removed in the april 27th revision.There is no problem with the product and it is operating normally.".

• Brand Name: SIMPLEX P-JAPANESE TWIN PACK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10072440
• MDR Text Key: 191533220
• Report Number: 0002249697-2020-00936
• Device Sequence Number: 1
• Product Code: LOD
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 61910002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 07/03/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention