MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 LOCKING SCREW; IMPLANT

Catalog Number UNK_KIE

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)

Event Date 03/19/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Implant disposition is unknown.

Event Description

It was reported that four-and-a-half years ago, tka with scorpio nrg ps and osteotomy with t2 femoral nail for oa with varus deformation were performed.A 3 months after the surgery, the varus deformation progressed and the most distal locking screw of t2 nail has come loose.The patient felt pain, so extraction of the screw was performed.Further 16 months after, patella fracture was occurred because the patient fall.Now, the patient feels no pain and walk by oneself, but the varus deformation of the femoral is remained.This case was presented at great expectations 2016 stryker (b)(4) hip & knee symposium on 3/19/2016.

• Brand Name: UNKNOWN T2 LOCKING SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5592153
• MDR Text Key: 43158320
• Report Number: 0009610622-2016-00214
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2016

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: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR