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

Catalog Number 6191-1-001

Device Problems Clumping in Device or Device Ingredient (1095); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the batch manufacturing records indicate packs were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

During cement mixing, cement remained clumpy and did not thoroughly mix.No adverse consequences to patient, the cement was discarded and a new dose was mixed.

Manufacturer Narrative

An event regarding the appearance of the cement involving simplex bone cement was reported.Conclusion: it is reported that the bone cement remained clumpy and did not thoroughly mix.It is also reported that the cement was mixed with foreign ingredients.The instructions for use leaflet (ifu) packaged with the subject device indicates that inclusion of any extraneous material such as blood or sterilization solutions into the mix must be avoided.It has been determined that this event is associated with an off-label application.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

During cement mixing, cement remained clumpy and did not thoroughly mix.No adverse consequences to patient, the cement was discarded and a new dose was mixed.After submission of the complaint pi the person who reported this found out information not previously disclosed; that the cement was mixed off label with foreign ingredients.

• 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: suzanne neuschwanter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6309386
• MDR Text Key: 66764495
• Report Number: 0002249697-2017-00488
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 07613327128444
• UDI-Public: (01)07613327128444(11)160826(17)180831(10)RHX114
• 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: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 6191-1-001
• Device Lot Number: RHX114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• 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