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Catalog Number 42532007501
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 12/03/2014
Event Type  Injury  
Event Description
It is reported that the patient was revised due to loosening.
Manufacturer Narrative
This report will be amended when our investigation is complete.
Manufacturer Narrative
Operative notes were not provided.Radiographs were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.Device history records were reviewed and found conforming.It is not suspected that the product failed to meet specifications.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.
Manufacturer Narrative
Device history records were reviewed and no deviations or anomalies were found.These devices are used for treatment.Updated information received via operative notes.Primary operative notes indicate trial reduction revealed excellent alignment, stability, and range of motion from 0 to 120 degrees.Final components were implanted with cement under pressurization technique.Primary operative notes do not indicate root cause.X-ray report dated (b)(6) 2014 indicates that the components had satisfactory alignment and fixation.X-ray report dated (b)(6) 2014 indicates there is a concern for tibial loosening and femoral loosening behind the anterior range.Lab results taken (b)(6) 2014 2014 indicate patient tested negative for infection with normal hemoglobin levels.Revision operative notes indicate the femoral component was found to be loosening due to what appeared to be osteolytic changes.The tibial component was found to be completely loose and the articular surface was severely pitted.The femoral and tibial components were explanted with minimal bone loss.A product history search revealed no additional complaints against the related part and lot combinations.A definitive root cause cannot be determined with the information provided.
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Brand Name
Manufacturer (Section D)
route 1, km. 123.4, bldg. 1
turpeaux industrial park
mercedita PR 00715
Manufacturer Contact
kevin escapule
po box 708
warsaw, IN 46581-0708
MDR Report Key4425614
MDR Text Key5376276
Report Number2648920-2015-00010
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Catalogue Number42532007501
Device Lot Number62268896
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/15/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient Weight91