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

Catalog Number	6188-1-001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate packs were manufactured and accepted into final stock with no reported discrepancies.There has been no other event reported for the manufacturing lot.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported by the attorney, through the filing of a lawsuit, that the patient underwent a left total hip arthroplasty on (b)(6) 2009 where she was implanted with a competitor hip resurfacing system.It is further alleged that her hip system failed and required revision of the femoral and tibial components on (b)(6) 2016.Update 10-aug-2018: legal department confirmed that the only stryker product involved in this event is simplex bone cement.The mention of tibial component was confirmed to be an error.On (b)(6) 2018- legal department confirmed that the patient did not have a knee surgery nor any stryker knee implant.

• Brand Name: SIMPLEX P HALF DOSE 1 PACK
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7774003
• Report Number: 0002249697-2018-02503
• Device Sequence Number: 1338428
• Product Code: LOD
• UDI-Device Identifier: 07613327128437
• UDI-Public: 07613327128437
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K062553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2018

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 Expiration Date: 12/31/2011
• Device Catalogue Number: 6188-1-001
• Device Lot Number: RDQ099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention