MAUDE Adverse Event Report: SYNTHES USA 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.265

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

Patient Problems Fall (1848); Hip Fracture (2349); Non-union Bone Fracture (2369); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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 with a history of right hip hemiarthroplasty fell and sustained a vancouver b fracture around the previously cemented femoral stem and right periprosthetic femur.On (b)(6) 2015, the patient underwent an open reduction internal fixation (orif) procedure of the right periprosthetic femur without revision of the stem.During the procedure, the patient was implanted with a synthes 18-hole right distal condylar plate with locking and unlocking screws.During the first postoperative visit, the patient was found to have a varus displacement of the stem and significant debilitation.The patient was returned to the operating room on (b)(6) 2015 to undergo a revision of the femoral component, to exchange the acetabular, and repeat the orif of the femoral fracture.It was noted that the stem was loose and had de-bonded from the cement mantle.There was also a mal-reduction of the proximal femoral fracture requiring takedown of the fracture and re-reduction.Assessment of the fracture itself indicated that there was a spiral oblique fracture with evidence of a coronal split in to the greater trochanter.The distal most screw and proximal cluster screws were removed and the plate was cut shorter by 3 holes to allow for appropriate reduction.Cerclage wires through the plate were used to protect propagation of the fracture.New hardware was implanted for the hip.This report is 2 of 14 for (b)(4).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5254097
• MDR Text Key: 32284589
• Report Number: 2520274-2015-17520
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR