MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN_KIE_PRODUCT; IMPLANT

Catalog Number UNK_KIE

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/01/2012

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device disposition is unknown.

Event Description

The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(4).The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of femoral fractures with the t2 nailing systems¿ which was published in november 2018 and is associated with the t2 femoral nailing system (t2 femur a/r).Within that publication, post-operative complications/ adverse events were reported, which occurred between november 2012 to september 2017.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 55 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses severe pain persistent 3 months after surgery (device-related).1 out of 2 cases.The report states, "subject 5-8 was a (b)(6) year old caucasian female, who fell from standing, injuring her right (closed isolated) femur.A t2 femur nail was placed in the retrograde, static compression mode, with 1 proximal locking a/p screw and 3 distal locking m/l screws.History significant for previous tobacco use, diabetes, osteoporosis, chronic right knee pain, right hip and back pain without history of trauma, degenerative joint disease, meniscal tear, and vitamin d deficiency; distal femur stress fracture prior to the day of admission found on an mri of the knee.Subject was discharged on pod#4, partial weightbearing.At the 3 month post-op follow-up visit, subject c/o pain and discomfort of the knee, medially.Fracture is healed.Subject was instructed to follow-up in 3 months or sooner if pain worsens.Surgeon noted distal most screw may be slightly long.Subject never returned for another follow-up.".

• Brand Name: UNKNOWN_KIE_PRODUCT
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8096089
• MDR Text Key: 128188188
• Report Number: 0009610622-2018-01475
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_KIE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2018
• 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): Other
• Patient Age: 39 YR