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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. BIPOLAR HIP SHELL, BIPOLAR, MODULAR, ENCORE, SIZE53

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ENCORE MEDICAL L.P. BIPOLAR HIP SHELL, BIPOLAR, MODULAR, ENCORE, SIZE53 Back to Search Results
Model Number 412-02-053
Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as instability. The previous surgery and the surgery detailed in this event occurred 25 days apart. The healthcare professional indicated there was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device was disposed of at the hospital and not made available to djo surgical for examination. A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event. The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery. Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review. The root cause of this complaint was a revision surgery due to instability. There were no findings during this evaluation that indicate that the reported devices were defective. No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event. There are multiple factors that may contribute to an event that are outside of the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, excessive range of motion, patient activities or trauma. Due to the short time between previous and revision surgery, it is also possible that the event may have been occurred due to lack of post-operative care, patient non-compliance with medical instructions, improper surgical technique or incorrect implant selection. There are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to instability. Conversion of hemiarthroplasty to total hip arthroplasty.
 
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Brand NameBIPOLAR HIP
Type of DeviceSHELL, BIPOLAR, MODULAR, ENCORE, SIZE53
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 78758-5445 
MDR Report Key9099475
MDR Text Key161857331
Report Number1644408-2019-00905
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number412-02-053
Device Catalogue Number412-02-053
Device Lot Number001C1086
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/16/2019
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: 09/20/2019 Patient Sequence Number: 1
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