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 Problems Pulmonary Edema (2020); Embolism/Embolus (4438)

Event Date 04/20/2022

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.

Event Description

Tha with stryker devices were performed after removal of the gamma type made by mdm (b)(4).After insertion of the exeter, the patient's blood pressure and saturation did not rise, and pulmonary embolus was suspected.The surgery was not interrupted and was continued to the end.The patient's condition is unknown.

Manufacturer Narrative

An event regarding patient factors involving a simplex cement mix was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: no medical records were provided for review with clinical consultant.-product history review: review of the device history records indicate packs were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays, patient history 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

Tha with stryker devices were performed after removal of the gamma type made by mdm japan.After insertion of the exeter, the patient's blood pressure and saturation did not rise, and pulmonary embolus was suspected.The surgery was not interrupted and was continued to the end.The patient's condition is unknown.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14403127
• MDR Text Key: 291833401
• Report Number: 0002249697-2022-00698
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 07613327128420
• UDI-Public: 07613327128420
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K014199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6197-9-001
• Device Catalogue Number: 6197-9-001
• Device Lot Number: MLC070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• 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): Other
• Patient Sex: Female