MAUDE Adverse Event Report: SYNTHES MONUMENT 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE; CERCLAGE FIXATION

Catalog Number 298.803S

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

Patient Problems Arthritis (1723); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as (b)(6).Other: udi: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Manufacturing location: (b)(4).Manufacturing date: april 19, 2010.Expiration date: march 31, 2019.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.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 that a patient who experienced longstanding hip arthritis, a history of groin pain, failed non-operative treatment (including oral anti-inflammatories) was examined and showed limited internal rotation.Additionally, x-rays showed obliteration of the joint space and the patient complained that pain on his left side was limiting his life including basic walking activities.Subsequently, the patient underwent a left total hip arthroplasty and open reduction internal fixation (orif) of a femur fracture; both the shaft and greater trochanter on (b)(6) 2012.The patient was implanted with a non-synthes trochanter plate, a synthes locking plate with eyelets for cables, three synthes 4.5mm threaded cerclage positioning pins and several non-synthes dall-miles-type cables.The patient was implanted with a total hip implant which in the end consisted of a size 56 pinnacle cup (non-synthes) with one acetabular screw and a metal on metal liner, a size 15 s-rom stem with a d large collar, 42 offset neck and a +3 femoral head.The patient was revised on (b)(6) 2013 due to left hip pain which began on or about (b)(6) 2013, possible subluxing hip, metallosis and removal of previously implanted hardware; two plates one proximal and one distal (one synthes plate and one non-synthes plate).The pain reportedly decreased over time but the patient reported feeling something moving in his hip and a bulging during the onset of pain.The patient reportedly elected to have the implanted devices removed.During the revision surgery on (b)(6) 2013, it was reported that the patient was noted to have a huge osteophyte that was coming up anteriorly over the anterior portion of the acetabulum and during range of motion this osteophyte would rub and pop on the acetabulum.The surgeon believed this is what was causing the patient to have the feeling that his hip was popping out of the joint.There was reportedly no evidence of subluxation or dislocation.The surgeon noted the anterior one-half of the trochanter was a non-union and there were multiple pieces of non-union but the posterior portion seemed to be intact.The trochanteric plate and a distal second plate and unknown non-synthes screws were removed.The patient was revised to a total hip and noted to be in satisfactory condition at the end of the procedure.X-rays taken showed excellent placement.Upon release the patient was reported to be ambulating well with the use of occupational therapy walker.Concomitant devices reported: non-synthes trochanter plate (part unknown, lot unknown, quantity 1), non-synthes dall-miles type cables (part 71340008 lot 11gsm0162, quantity 6), non-synthes screws (part unknown, lot unknown, quantity unknown).This is report 2 of 4 for (b)(4).

• Brand Name: 4.5MM THREADED CERCLAGE POSITIONING PIN-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: 6148595
• MDR Text Key: 61537810
• Report Number: 1719045-2016-10881
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 298.803S
• Device Lot Number: 6365571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 6 PART71340008,LOT11GSM0162,DALL-MILESTYPE CABLES; ONE UNKNOWN NON-SYNTHES TROCHANTER PLATE; UNKNOWN QUANTITY OF UNKNOWN NON-SYNTHES SCREWS
• Patient Outcome(s): Required Intervention
• Patient Weight: 68