MAUDE Adverse Event Report: SYNTHES USA; ROD,FIXATION,INTRAMEDULLARY

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient¿s identifier and weight are unknown.One week after the first revision surgery the femoral head started rotating, however the date of the blade cut out of the femoral date is unknown.This report is for one (1) unknown blade.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant device is not expected to be returned for manufacturer review/investigation.Unknown, as specific part and lot numbers for blade is not provided.Reporter phone number is not provided for reporting.Without a lot number, the device history records review could not be completed.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

Device report from synthes (b)(4) reports an event in (b)(6)as follows: it was reported that the femoral head started rotating one week after the revision surgery performed on (b)(6) 2017.The blade cut out of the femoral head.The replacement surgery for bipolar hip arthroplasty could not be initiated soon to the patient.On (b)(6) 2017, one (1) month after the first revision surgery, the bipolar hip arthroplasty was performed.No surgical delay is reported.Patient outcome is reported as good.The patient was revised twice.This report addresses second revision performed on (b)(6) 2017.The first revision, which was performed on (b)(6) 2017 has been reported under linked complaint (b)(4).Concomitant device reported: trochanteric fixation nail advanced (tfna) nail (part # unknown, lot # unknown, quantity 1).This report is for one (1) unknown blade.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

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.

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6893432
• MDR Text Key: 87352951
• Report Number: 2520274-2017-12334
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR