MAUDE Adverse Event Report: SYNTHES MONUMENT 1.7MM COCR CABLE WITH TI CRIMP750MM-STERILE; CERCLAGE FIXATION

Catalog Number 611.105.01S

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).Device return will not be requested as this is a legal case.The investigation could not be completed; no conclusion could be drawn, as no product was received.Part #: p011255, lot#: 611.105.01s (sterile) - 1.7mm cocr cable with ti crimp 750mm - sterile.Quantity 61.No ncrs were generated during production.Review of the device history record(s) showed that there were no other issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ part #: p011255, lot#: 611.105.01s (sterile) - 1.7mm cocr cable with ti crimp 750mm - sterile.Quantity 75.No ncrs were generated during production.Review of the device history record(s) showed that there were no other issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ 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 a patient underwent a revision surgery for a hip replacement on (b)(6) 2016, due to increasing pain in the hip with infection and drainage.The hardware was removed and the infected area was debrided and irrigated.The patient was revised to non-synthes hardware.There was no reported surgical delay; the patient's outcome was reported as stable.The patient was initially implanted with the hardware; a non-synthes total hip system (captured in (b)(4)) and five (5) synthes cocr cables with titanium crimp on (b)(6) 2007.Concomitant devices reported: depuy s-rom total hip system femoral stem left xxlong (part # 56-3160l, lot # 2131883, quantity #1), depuy s-rom total hip system ztt proximal sleeve (part # 52-1403, lot # 2474892, quantity #1), depuy asr femoral implant (part # 9998-90-253, lot # 2183575, quantity #1), depuy asr taper sleeve adaptor (part # 9998-90-340, lot # 2444685, quantity #1).This report is 3 of 5 for (b)(4).

• Brand Name: 1.7MM COCR CABLE WITH TI CRIMP750MM-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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6015514
• MDR Text Key: 56918389
• Report Number: 1719045-2016-10745
• 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
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 611.105.01S
• Device Lot Number: P011252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: (PART # 52-1403, LOT # 2474892, QUANTITY #1); (PART # 56-3160L, LOT # 2131883, QUANTITY #1); (PART # 9998-90-253, LOT # 2183575, QUANTITY #1); (PART # 9998-90-340, LOT # 2444685, QUANTITY #1)
• Patient Outcome(s): Required Intervention