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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X380MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X380MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 34250380S
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Failure of Implant (1924); Nerve Damage (1979); Pain (1994); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Unequal Limb Length (4534); Implant Pain (4561)
Event Date 08/12/2017
Event Type  Injury  
Manufacturer Narrative
The reported device is not available as it is the subject of a legal matter. If additional information becomes available, it will be provided in a supplemental report. Device not available.
 
Event Description
It is alleged by the patient, through the filing of a legal claim, that the patient underwent a right total knee replacement on (b)(6) 2017 due to pain and maltracking patella syndrome. It is further alleged that on (b)(6) 2017 the patient had a stryker locking screw inserted into her broken right femur along with a gamma 3 system long nail. On (b)(6) 2018, about 6 months post-op, the patient began to experience pain. X-rays revealed that the locking screw snapped, causing the gamma 3 long nail kit to travel into the patient¿s knee area. This resulted in the patient¿s right leg being 1 inch shorter than her left and she now walks with a limp. Its also alleged that this has also aggravated her sciatic nerve pain in her lower back that she had been dealing with prior to having the stryker components implanted.
 
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Brand NameLONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X380MM X 125
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8974211
MDR Text Key156892098
Report Number0009610622-2019-00641
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200869
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Catalogue Number34250380S
Device Lot NumberK07C5E2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/10/2017
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: 09/09/2019 Patient Sequence Number: 1
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