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

Catalog Number 6197-9-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding alleged loosening involving a simplex cement mix was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records by a clinician indicated the following: there is no clinical or radiographic evidence to confirm ¿cement has come loose¿.Bone cement is not glue, it is a seating material similar to cementing a fence post into the ground.Inadequate cement mantel and poorly designed implant/cement interfaces can compromise fixation.There is no evidence that the properties of the bone cement used in this case were responsible for any clinical problems.Communication from stryker orthopaedics indicates the bone cement used in this case was not the subject of a recall.Device history review: a review of the batch manufacturing records indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event itself could not be confirmed, nor could the exact cause of the event be determined.A review of the provided medical records by a clinician indicated the following: there is no clinical or radiographic evidence to confirm ¿cement has come loose¿.Bone cement is not glue, it is a seating material similar to cementing a fence post into the ground.Inadequate cement mantel and poorly designed implant/cement interfaces can compromise fixation.There is no evidence that the properties of the bone cement used in this case were responsible for any clinical problems.

Event Description

Patient called and stated that she had a right knee replacement with competitor parts (b)(6) 2012.The bone cement has come loose on the top and bottom.

• Brand Name: SIMPLEX P WITH TOBRAMYCIN 1 PACK
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7437003
• MDR Text Key: 105698769
• Report Number: 0002249697-2018-01151
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2003
• Device Catalogue Number: 6197-9-001
• Device Lot Number: MBT006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2012
• 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
• Patient Age: 56 YR
• Patient Weight: 82