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

Catalog Number 61910001

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicates the ten-pack devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.This lot number was used with another unit of the same lot, however they were mixed together and used during the same surgery in the same patient.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Customer reported a suspected septic mobilization following an implant with competitor devices and stryker simplex bone cement.(competitor cement plug).

Manufacturer Narrative

Additional information: date of implant; date of explant.An event regarding infection involving simplex cement mix was reported.The event was confirmed by medical review.Method & results: - device evaluation and results: not performed as the device was not returned for evaluation.- medical records received and evaluation: revision of non-stryker samo stem fixed with stryker simplex-p bone due to infection some 6-weeks post implantation in an (b)(6) year old patient with no further details provided.All components were removed leaving an irrigation drain in the hip.X-rays confirm implantation of a samo (non stryker) stem with bipolar head.When infectious complications developed was not reported but within 6-weeks of arthroplasty all devices were removed on or around (b)(6) 2017, although some bone cement was retained in the mid and distal stem section including the non-stryker cement restrictor.As far as the role of the stryker simplex-p bone cement is concerned, we should be aware that bone cement is not a primary cause for infection and only serves a secondary role to provide device fixation, in this case for a non-stryker stem as manufactured by samo and a non-stryker cement restrictor as manufactured by (b)(4).- device history review: indicated all product was accepted into final stock with no reported discrepancies.- complaint history review: there have been no other events for the lot or sterile lot referenced.Conclusion: the medical review concluded infection is primarily a procedure-related complication generic to every arthroplasty with sometimes additional patient-related risk factors about which there is no explicit information in this case.The severity of infection required all devices to be removed within 6-weeks of implantation possibly leaving the hip as a girdlestone condition.The exact cause of the event could not be determined as insufficient information was provided.Further information such as pathology reports including the strain of infection as well operative reports, patient history and follow up notes are required for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.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

Customer reported a suspected septic mobilization following an implant with competitor devices and stryker simplex bone cement.(competitor cement plug).

• Brand Name: SURGICAL SIMPLEX CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7096663
• MDR Text Key: 94141008
• Report Number: 0002249697-2017-03513
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K093644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 61910001
• Device Lot Number: CCY026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR