MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LONG GAMMA3 NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 05/09/2014

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.

Event Description

The manufacturer became aware of a literature published by gangnam severance hospital, yonsei univeristy college of medicine in korea.The title of this report is ¿atypical femoral fracture combined with osteonecrosis of jaw during osteoporosis treatment with bisphosphonate¿ published on may 9, 2014, which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at http://dx.Doi.Org/10.11005/jbm.2014.21.2.155.This report includes a case study done on 1 patient.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses pain due to nonunion and nail breakage followed by revision surgery.The report states: after three years of operation, she showed up at our out-patient department with pain in the right hip joint while walking despite no evidence of trauma.On the radio¬graph, nonunion of subtrochanteric fracture and breakage of long gamma-3 nail was noticed [.] we removed the broken nail and exchanged to cephalomedullary nail¬ing and autogenous iliac bone graft was done.

• Brand Name: UNKNOWN LONG GAMMA3 NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11414435
• MDR Text Key: 234727818
• Report Number: 0009610622-2021-00325
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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
• Date Manufacturer Received: 02/10/2021
• 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: 67 YR
• Patient Weight: 55