MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_STRYKER CEMENT; BONE CEMENT

Catalog Number UNK_LIM

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problems Pain (1994); Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient complained of pain.Piece of cement was in the posterior aspect of the joint.Liner was removed and the cement.New liner was implanted.

Manufacturer Narrative

An event regarding user error involving a unknown cement mix was reported.The event was confirmed.Method and results: device evaluation could not be performed as the subject device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "the primary harm involved is revision surgery due to a technical complication from the index procedure.Following implantation of the pkr in the index surgery the extruded cement was not completely removed in the posterior aspect of the articulation.This led to a mechanical complication pain necessitating revision surgery.One of the difficulties encountered and performing partial knee replacement is limited visualization afforded to the surgeon particularly in the posterior aspect of your articulation.No implant or manufacturing defect was identified in this review." conclusions: a review of the provided medical records by a clinical consultant indicated "the primary harm involved is revision surgery due to a technical complication from the index procedure.Following implantation of the pkr in the index surgery the extruded cement was not completely removed in the posterior aspect of the articulation.This led to a mechanical complication pain necessitating revision surgery.One of the difficulties encountered and performing partial knee replacement is limited visualization afforded to the surgeon particularly in the posterior aspect of your articulation.No implant or manufacturing defect was identified in this review." no further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Patient complained of pain.Piece of cement was in the posterior aspect of the joint.Liner was removed and the cement.New liner was implanted.

• Brand Name: UNKNOWN_STRYKER CEMENT
• 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: 5787413
• MDR Text Key: 49333316
• Report Number: 0002249697-2016-02249
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

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 Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 87