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U.S. Department of Health and Human Services

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

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STRYKER TRAUMA KIEL UNKNOWN SHORT GAMMA3 NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Separation Problem (4043)
Patient Problems Pain (1994); Injury (2348)
Event Date 05/23/2016
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 maastricht university medical center, in netherlands. The title of this report is ¿late occurring medial migration of a lag screw in gamma nailing¿ which is associated with the stryker ¿gamma3 nailing¿ prosthesis system. The article can be found at http://dx. Doi. Org/10. 1155/2016/5201674. Within that publication which included single patient, post-operative complications were reported. 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 acute pain and inability to walk for 2 days with medial migration of the lag screw which was treated by removal of gamma nail and replacement by a cemented total hip arthroplasty. The report states: ¿unfortunately, three months after the operation the patient presented herself again in the ed with acute pain in her left hip for 2 days and an inability to walk. There was no preceding trauma and there were no signs of an infection. The x-ray in the ed showed medial migration of the lag screw (figure 5). It was decided to remove the gamma nail and replace it by a cemented total hip arthroplasty (exeter stem, rimfit cup, stryker) during the same session. Intraoperatively, the fracture appeared consolidated and there were no signs of infection. ¿.
 
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Brand NameUNKNOWN SHORT 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 Key10417709
MDR Text Key203295987
Report Number0009610622-2020-00472
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2020
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 Received07/21/2020
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: 08/17/2020 Patient Sequence Number: 1
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