MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P WITH TOBRAMYCIN 1 PACK; BONE CEMENT

Model Number 6197-9-001

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/24/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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

As reported: "[the patient] had a loose body (bone cement) that was successfully removed arthroscopically.".

Event Description

As reported: "[the patient] had a loose body (bone cement) that was successfully removed arthroscopically.".

Manufacturer Narrative

Updated the implant date.Reported event: an event regarding additional surgery due to loose body involving simplex cement mix was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Clinician review: the available medical records were provided to the consulting clinician for a review which concluded," there is no relation between the mako implants and the complaint.Obtaining the loose bodies or a pathology report of their exam would confirm if they were cement remnants.Obtaining the x-rays may confirm presence of a loose body or loose and / or extraneous cement.Extraneous cement would generally be a surgical technique issue rather than an implant issue in the absence of evidence implant failure." device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient had a loose body (bone cement) that was successfully removed arthroscopically.The available medical records were provided to the consulting clinician for a review who deemed it insufficient to confirm the event.The event could not be confirmed nor the exact cause of the event could be determined because insufficient information was available with stryker.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.

• Brand Name: SIMPLEX P WITH TOBRAMYCIN 1 PACK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10061303
• MDR Text Key: 191115010
• Report Number: 0002249697-2020-00904
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 07613327128420
• UDI-Public: 07613327128420
• Combination Product (y/n): N
• PMA/PMN Number: K014199
• 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: 07/29/2020

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 Expiration Date: 12/31/2020
• Device Model Number: 6197-9-001
• Device Catalogue Number: 6197-9-001
• Device Lot Number: MEA035
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 07/05/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR