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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P WITH TOBRAMYCIN 1 PACK; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 6197-9-001
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Cardiac Arrest (1762)
Event Date 08/29/2023
Event Type  Injury  
Event Description
The patient with pathological fracture of right femur due to prostate cancer metastasis underwent gmrs femoral arthroplasty and bipolar hip arthroplasty on (b)(6) 2023.After cement was injected into the femur and the gmrs stem was inserted, the patient suddenly suffered cardiac arrest during waiting polymerisation.While cpr was performed and rosc was confirmed 7 minutes after cardiac arrest, the surgery was discontinued.
 
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.H3 other text : not returned.
 
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Brand Name
SIMPLEX P WITH TOBRAMYCIN 1 PACK
Type of Device
BONE CEMENT, ANTIBIOTIC
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 Key17824142
MDR Text Key324342672
Report Number0002249697-2023-01078
Device Sequence Number1
Product Code MBB
UDI-Device Identifier07613327128420
UDI-Public07613327128420
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K014199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 09/27/2023
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 Number6197-9-001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/29/2023
Initial Date FDA Received09/27/2023
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 Number1
Patient Outcome(s) Other;
Patient Age80 YR
Patient SexMale
Patient Weight52 KG
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