MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Kim, et al (2016) successful outcome with minimally invasive plate osteosynthesis for periprosthetic tibial fracture after total knee arthroplasty.Orthopaedics & traumatology: surgery & research 103;263-268.This report is for unknown screw, unknown quantity, unknown lot.Other number: udi: unknown part number, udi is unavailable.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received.This report is being filed after the subsequent review of the following literature article: kim,.Et al (2016) successful outcome with minimally invasive plate osteosynthesis for periprosthetic tibial fracture after total knee arthroplasty.Orthopaedics & traumatology: surgery & research 103;263-268.Sixteen patients with periprosthetic tibial fracture after total knee arthroplasty (tka) were included.There were 6 type ii and 10 type iii fractures according to the felix classification.Ten patients had fractures in the proximal metaphysis, and 6 in the diaphysis.Minimally invasive plate osteosynthesis (mipo) technique using locking plates was performed on the medial side in 4 cases, the lateral side in 2 cases, and both in 10 cases.Either pre-shaped locking compression plate - proximal lateral tibia (lcp-plt; synthes, (b)(4)), locking compression plate - medial proximal tibia (lcp-mpt;synthes), or narrow locking compression plate (narrow lcp;synthes) were used.The reason for tka was osteoarthritis in 11 patients, rheumatoid arthritis in 2 patients, osteosarcoma in 2 patients and ankylosis caused by osteomyelitis in 1 patient.The mean age was 62.8 (range, 16¿85 years); there were 13 women and 3 men.The mean interval between tka and periprosthetic fracture was 46.6 months (range, 1¿150 months).Fourteen of 16 fractures achieved union at 17.1 weeks.This is report 2 of 4 for (b)(4).This report is for unknown screw and refers to the following: (b)(6) female- lcp medial locking plate- experienced superficial infection with redness and heat with soft tissue irritation caused by loosened screws at the proximal side due to insufficient stability.-the plate was removed before union to treat the infection.

• Type of Device: SCREW, FIXATION, BONE
• 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: 6559864
• MDR Text Key: 74937312
• Report Number: 2520274-2017-11625
• Device Sequence Number: 1
• Product Code: HWC
• 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: Other
• Type of Report: Initial
• Report Date: 04/13/2017

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2017
• Initial Date FDA Received: 05/11/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR