MAUDE Adverse Event Report: SYNTHES MONUMENT 1.7MM CABLE WITH CRIMP 750MM-STERILE; CERCLAGE FIXATION

Catalog Number 298.801.01S

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional events were captured by depuy (b)(4).(b)(4).Device is not expected to be returned for manufacturer review/investigation.Device history record review concluded that no ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition for part #298.801.01s lot #p149378, release to warehouse date:16-may-2013,expiration date: 31-mar-2018 and supplier: (b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported the patient had advanced osteoarthrits and avascular necrosis in the left hip related to an work injury.He had a left total hip arthroplasty (b)(6) 2009.The patient developed pain in the left hip and was diagnosed with chronic infection in the left hip arthroplasty.On (b)(6) 2013, the patient had his left hip explanted, placement of a temporary antibiotic cement spacer and open reduction internal fixation (orif) of the femur.Eight synthes cerclage wires were used to reappropriate the bone onto the prostalac, re-establishing the femoral tube.On (b)(6) 2013, the patient had another left hip revision, removal of temporary antibiotic cement spacer, scar revision, previous cerclage wires were removed and an (orif) greater trochanter.The patient was doing well, but removed the hip abduction brace and sustained a greater trochanteric fracture due to weakened bone from the surgery.On (b)(6) 2014 ,the patient underwent a left hip (orif), femoral strut graft placing and scar revision.The patient continued to drain post-operatively but had purulent drainage, wound dehiscence with a foul odor.On (b)(6) 2014, the patient had left hip irrigation, debridement and placement of re-absorbable antibiotic cement pellets.Final patient outcome unknown.This is report number 5 of 8 for (b)(4).

Manufacturer Narrative

Patient code (b)(4) refers to revision surgery from (b)(6) 2013 where patient had his left hip explanted, placement of a temporary antibiotic cement spacer and open reduction internal fixation (orif) of the femur device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The initial complaint was reviewed and found not reportable.There is no allegation of a complaint against this device, there is no reported malfunction.This device was removed as part of a planned revision surgery and there was no allegation of malfunction reported.If additional information becomes available, this determination will be re-reviewed by a clinician.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.7MM CABLE WITH CRIMP 750MM-STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6122709
• MDR Text Key: 60742366
• Report Number: 1719045-2016-10845
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2016

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: 03/31/2018
• Device Catalogue Number: 298.801.01S
• Device Lot Number: P149378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/30/2016; 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 86