MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 KNEE ARTHRODESIS NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Separation Problem (4043)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from university of cincinnati medical center, in usa.The title of this report is ¿a retrospective data collection of the treatment of long bone fractures with the t2 knee arthrodesis nailing system (t2 kan)¿ which is associated with the stryker ¿t2 knee arthrodesis nailing system¿.This study includes research done on 4 patients requiring surgery between the period january 1, 2013 to december 31, 2018.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses distal locking screw loosening, pain and irritation at the screw site for which hardware was removed 10.5 months postoperatively.The report states: ¿patient one is a 57-year-old female who had a left knee arthrodesis performed.They had a distal locking screw become loose and prominent and has dealt with pain and irritation at the screw site.Therefore, after discussing risks, benefits and alternatives of treatment, they elected to undergo surgical removal of hardware at 10.5 months postoperatively.Culture and biopsy were negative for infection or pathologic bone.¿.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from (b)(6), in usa.The title of this report is ¿a retrospective data collection of the treatment of long bone fractures with the t2 knee arthrodesis nailing system (t2 kan)¿ which is associated with the stryker ¿t2 knee arthrodesis nailing system¿.This study includes research done on 4 patients requiring surgery between the period (b)(6), , 2013 to (b)(6), , 2018.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses distal locking screw loosening, pain and irritation at the screw site for which hardware was removed 10.5 months postoperatively.The report states: ¿patient one is a 57-year-old female who had a left knee arthrodesis performed.They had a distal locking screw become loose and prominent and has dealt with pain and irritation at the screw site.Therefore, after discussing risks, benefits and alternatives of treatment, they elected to undergo surgical removal of hardware at 10.5 months postoperatively.Culture and biopsy were negative for infection or pathologic bone.¿.

Manufacturer Narrative

Correction: section d5.

• Brand Name: UNKNOWN T2 KNEE ARTHRODESIS NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10726398
• MDR Text Key: 212793842
• Report Number: 0009610622-2020-00576
• 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: study
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR