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

Catalog Number 6191-1-001

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2017

Event Type  malfunction  

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.Review of the batch manufacturing records indicates ten packs were manufactured and accepted into final stock with no reported discrepancies.Lot rlx184., is made up of powder lot 501kx1 and liquid lot 958kx which were also reviewed and no discrepancies noted.There has been no other event for the lot referenced.

Event Description

Sales rep reported surgeon did not want to use the cement after mixing as it looked like there was glass.

Manufacturer Narrative

An event regarding alleged glass fragments found in simplex cement mix was reported.The event was not confirmed.Method & results: -device evaluation and results: no product was returned for analysis, photographs were attached which shows small brown particles/ contaminate embedded in what appears to be hardened/set bone cement.-medical records received and evaluation: not performed as the product was not implanted.Conclusions: an event regarding alleged glass fragment found in mixed bone cement could not be confirmed.Foreign matter can be observed in the cement mix attached in the photograph provided by the customer.However as the sample containing the cement mix was then discarded by the customer no material analysis of the foreign matter could be performed.Further information such as product return is required to complete this investigation and determine 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

Sales rep reported surgeon did not want to use the cement after mixing as it looked like there was glass.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6444260
• MDR Text Key: 71210985
• Report Number: 0002249697-2017-01071
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 07613327128444
• UDI-Public: (01)07613327128444(11)161130(17)190930(10)RLX184
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062553
• 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: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RLX184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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): Other