MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 SHORT NAIL 11X180; IMPLANT

Catalog Number UNK_KIE

Device Problem Collapse (1099)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Hospital retained.

Event Description

It was reported that the patient's right femur was revised due to collapse of the patient's femoral neck (non-union).Surgeon reported the devices were not responsible for the failure, but due to several patient factors (poor protoplasm, smoking, and other factors).The gamma3 short nail, lag screw, and locking screw were revised to a hip replacement with restoration modular devices.Rep confirmed that no further information is available.

• Brand Name: UNKNOWN GAMMA3 SHORT NAIL 11X180
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9307312
• MDR Text Key: 170520355
• Report Number: 0009610622-2019-00917
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/16/2019
• 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: 54 YR