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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Separation Problem (4043)
Patient Problem Injury (2348)
Event Date 08/20/2014
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. Device disposition is unknown.
 
Event Description
The manufacturer became aware of a literature published by (b)(6). The title of this report is ¿causes and treatments of lag screw¿s cut out after intramedullary nailing osteosynthesis for trochanteric fractures¿ which is associated with the stryker ¿gamma3¿ nailing system. The article can be found at https://www. Mattioli1885journals. Com/index. Php/actabiomedica/article/view/2912. Within that publication which included 20 patients, post-operative complications were reported, which allegedly occurred from september 2004 to november 2010. 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 cut out of lag screw which was treated by total hip arthroplasty. The report states: ¿the treatment performed was: in 1 patient the removal of the implant, in 3 cases the reosteosynthesis (in 2 cases only of the lag screw) and in 16 patients hip arthroplasty: 13 total and 3 partial hip arthroplasty [. ] causes of cutting out (mechanical, biological, mixed) mechanical (malposition of the lag screw) [. ] time of cutting out (months) 36 [. ] treatment total hip arthroplasty: revision modular stem + acetabular cup¿.
 
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Brand NameUNKNOWN GAMMA3 NAIL
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10334421
MDR Text Key201043953
Report Number0009610622-2020-00386
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
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 Treatment Data
Date Received: 07/28/2020 Patient Sequence Number: 1
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