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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN 10*400 T2 ALPHA FEMORAL NAIL PF LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL UNKNOWN 10*400 T2 ALPHA FEMORAL NAIL PF LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Impaired Healing (2378); Swelling/ Edema (4577)
Event Date 12/13/2021
Event Type  Injury  
Event Description
The manufacturer became aware of a pmcf final study report that was conducted by university of louisville in the usa. The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail greater trochanter (pf) of the t2 alpha femur antegrade gt/pf nailing, which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing¿ system. This report includes analysis of the clinical data that was collected on 28 patients, the cases in this study range from march 2019 through august 2020. During the review of the literature, it was not possible to establish a specific device details, patient information, and at this time no additional device information is available. It was reported that one patient experienced gt bursitis and was referred for physical therapy. The report states: ¿patient k: the following patient had gt bursitis: patient was (b)(6)female, bmi 29. 9, nonsmoker, with long term use of bisphosphonates, and history of dementia. Her injury was due to falling from standing and was classified as closed 32-a2 fracture. The devise used for the initial fixation surgery was 10*400 t2 alpha femoral nail pf left, with recon locking mode. The gt bursitis was diagnosed 98 days post-op along with interval bone healing, patient was able to weight bearing as tolerated (wbat) and was referred for physical therapy then lost follow up. ¿.
 
Manufacturer Narrative
This complaint has been generated based on findings discovered during post market surveillance pmcf study review. The alleged gt bursitis and was referred for physical therapy included in the study could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available. More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause. If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly. Device disposition is unknown.
 
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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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13266423
MDR Text Key285615116
Report Number0009610622-2022-00021
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study
Reporter Occupation
Type of Report Initial
Report Date 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2022
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
Date Manufacturer Received12/19/2021
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: 01/17/2022 Patient Sequence Number: 1
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