MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 2.0MM 22-13-5 SS CABLE/SLV SET; CERCLAGE, FIXATION

Catalog Number 3704-0-510

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 05/20/2014

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: 2.0mm 22-13-5 ss cable/slv set; cat# 3704-0-510; lot# 46790102, 2.0mm 22-13-5 ss cable/slv set; cat# 3704-0-510; lot# 46790108, simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mlu112, simplex p with tobramycin 1 pack; cat# 6197-9-001; lot# mlu112.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding alleged infection involving a dall miles cable was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned for evaluation.Medical records received and evaluation: a review of the operative reports, office notes, x-rays by the consulting clinician indicated "there is no examination of explanted components and no bacterial culture confirming an organism which may have been masked by pre-operative intravenous antibiotics.Pre­ operative sed rate and benign x-rays and frozen sections do not confirm sepsis.There is no documentation of recurrent drainage or "ion concentrations in the thousands" as noted in the operative report of (b)(6) 2014.Evaluation of hip pain is difficult in the multiple emergency room visits of this narcotic dependent, non-compliant patient.Based on the available medical records there is no convincing evidence in operative reports or radiology reports that there are any factors of implant design, manufacturing or materials of the revision components (the only stryker components) that were responsible for this complicated clinical picture." device history review 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 and sterile lot.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.A review of the operative reports, office notes, x-rays by the consulting clinician indicated "there is no examination of explanted components and no bacterial culture confirming an organism which may have been masked by pre-operative intravenous antibiotics.Pre­ operative sed rate and benign x-rays and frozen sections do not confirm sepsis.There is no documentation of recurrent drainage or "ion concentrations in the thousands" as noted in the operative report of (b)(6) 2014.Evaluation of hip pain is difficult in the multiple emergency room visits of this narcotic dependent, non-compliant patient.Based on the available medical records there is no convincing evidence in operative reports or radiology reports that there are any factors of implant design, manufacturing or materials of the revision components (the only stryker components) that were responsible for this complicated clinical picture." a capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Product surveillance will continue to monitor for trends.

Event Description

On (b)(6) 2015 his prosthesis (competitor product) was removed and a revision of the right total hip was performed for a diagnosis of "status-post infected right hip status-post prosthesis (competitor product) placement".[.]"the report notes, "cultures negative, esr and crp normal, off antibiotics.".

• Brand Name: 2.0MM 22-13-5 SS CABLE/SLV SET
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7031240
• MDR Text Key: 92456146
• Report Number: 0002249697-2017-03326
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2019
• Device Catalogue Number: 3704-0-510
• Device Lot Number: 46593001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• 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: 35 YR
• Patient Weight: 77