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

Catalog Number UNK_KIE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Date 08/23/2013

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of adverse events from the norwegian hip fracture register.The title of this report is ¿gamma 3 in the norwegian hip fracture register¿ which is associated with the gamma 3 locking nail system, within that report, postoperative complications/ adverse events were reported, which occurred between 1-jan-2005 and 31-dec-2016.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 290 complaints were initiated for the revision surgeries retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision surgery due to haematoma.Case 119 out of 290 cases.

• Brand Name: UNK GAMMA3 LONG
• 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: melissa guattery ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7763903
• MDR Text Key: 116455943
• Report Number: 0009610622-2018-00612
• Device Sequence Number: 0
• Product Code: HSB
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2018
• 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): Required Intervention