MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MD.UNIVERSAL CEMENT RESTRICTOR; IMPLANT

Catalog Number B000-0240

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 02/07/2014

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was discarded and 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

It was reported that the largest fin of the medium universal cement plug (with inserter cat#b000-1240) was came off from the body of the cement plug, so easily when the surgeon tried to insert into the femoral canal which was reamed 14mm during proximal femoral replacement with gmrs.So, the surgeon used spare universal plug (no inserter cat#b000-0240).The largest fin of the spare cement plug was also came off so easily from the body during inserting the canal at the proximal area of the femur.Another cement plug(osteonics sized cement-plug) was used instead of it and the procedure was completed.The surgeon requests us to investigate detailed investigation of the strength of the universal plug fin.

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot the event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

It was reported that the largest fin of the medium universal cement plug (with inserter cat#b000-1240) was came off from the body of the cement plug so easily when the surgeon tried to insert into the femoral canal which was reamed 14mm during proximal femoral replacement with gmrs.So, the surgeon used spare universal plug(no inserter cat#b000-0240).The largest fin of the spare cement plug was also came off so easily from the body during inserting the canal at the proximal area of the femur.Another cement plug(osteonics sized cement-plug) was used instead of it and the procedure was completed.The surgeon requests us to investigate detailed investigation of the strength of the universal plug fin.

• Brand Name: MD.UNIVERSAL CEMENT RESTRICTOR
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3662292
• MDR Text Key: 19389222
• Report Number: 0002249697-2014-00644
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931847
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2014

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: 06/30/2018
• Device Catalogue Number: B000-0240
• Device Lot Number: 6M8532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 03/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2013
• 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
• Patient Age: 54 YR