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

Model Number	6197-9-001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pulmonary Edema (2020); Embolism/Embolus (4438)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0002249697-2022-00698
• Device Sequence Number: 5301557
• Product Code: LOD
• UDI-Device Identifier: 07613327128420
• UDI-Public: 07613327128420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K014199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female