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

Catalog Number 6191-1-001

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.There has been 01 other event for the lot referenced.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

As per received medical records: "closed reduction, right hip, mold." patient was implanted with competitor and stryker cement on (b)(6) 2016.

Manufacturer Narrative

An event regarding dislocation involving a simplex cement was reported.Conclusions: based on the provided information, the product reported in this investigation did not contribute to the event as the dislocation occurred between the uhr head cement mold and the acetabulum.The cement was used to fill the mold and cement the stem proximally.No allegations were made against the reported device.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As per received medical records: "closed reduction, right hip, mold." patient was implanted with competitor and stryker cement on (b)(6) 2016.

• Brand Name: SIMPLEX P FULL DOSE 1 PACK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8199032
• MDR Text Key: 131484217
• Report Number: 0002249697-2018-04140
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 07613327128444
• UDI-Public: 07613327128444
• Combination Product (y/n): N
• PMA/PMN Number: K062553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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 Expiration Date: 12/31/2018
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RDX049
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR