MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX TOBRAMYCIN 1 PK; BONE CEMENT

Catalog Number 61971001

Device Problem Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Rash (2033); Swelling (2091); Reaction (2414); Increased Respiratory Rate (2486)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The customer reported that the patient had a reaction to the cement which included itching, increased blood pressure, increased respiration, widespread rash, swelling of eyes and face.The patient was treated with adrenaline for an anaphylactic reaction and will be managed in itu.It was not known prior to surgery whether the patient was allergic to any of the constituents of the cement.

Manufacturer Narrative

An event regarding an allergic reaction involving simplex bone cement was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the cement was not returned.Medical records received and evaluation: not performed as no medical records were provided for review.Device history review: indicates product was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: the investigation concluded that the reported allergic reaction cannot be confirmed.The exact cause of the event could not be determined due to lack of information provided.Further information such as the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining a root cause.No further investigation for this event is possible at this time.If additional information becomes available this investigation will be reopened.

Event Description

The customer reported that the patient had a reaction to the cement which included itching, increased blood pressure, increased respiration, widespread rash, swelling of eyes and face.The patient was treated with adrenaline for an anaphylactic reaction and will be managed in itu.It was not known prior to surgery whether the patient was allergic to any of the constituents of the cement.

• Brand Name: SIMPLEX TOBRAMYCIN 1 PK
• 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
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6344301
• MDR Text Key: 67817008
• Report Number: 0002249697-2017-00610
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 61971001
• Device Lot Number: TCX011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2016
• 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): Hospitalization; Required Intervention