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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. AGILITY TIBIAL SHELL SZ 4 LT ANKLE IMPLANT

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DEPUY ORTHOPAEDICS, INC. AGILITY TIBIAL SHELL SZ 4 LT ANKLE IMPLANT Back to Search Results
Catalog Number 155524000
Device Problems Break; Metal Shedding Debris; Appropriate Term/Code Not Available; Noise, Audible
Event Date 10/08/2014
Event Type  Injury  
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).

 
Event Description

Update 2/17/2016 medical records received. Medical records reviewed for mdr reportability. Medical records reported discomfort, pain, moderate varus alignment, ankle deformity, stiffness. Radiographs reportedly showed malaligned with lucency over posterior and anterior aspects, broken tibial component and subluxation of the talar component. Revision surgery note reported metallosis, metal debris, clicking and moving parts reported by patient, difficulty ambulating, and the distal tibia with 2 bone cysts. On (b)(6) 2016 x-ray received attached to complaint (b)(4). On (b)(6) 2016- update-radiograph review findings indicate a fracture of the tibial implant.

 
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
Manufacturer Narrative

Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
Manufacturer Narrative

Conclusion and justification status for mdr: the device associated with this report was not returned. Provided patient x-rays were reviewed and images dated (b)(6) 2013 and (b)(6) 2014 show the fractured tibial component, confirming the reported complaint event. No other implant fracture or implant disassociation was noted. Review of patient medical records state the patient was obese; among other conditions, it is known that excessive patient weight tends to adversely affect the overall success of replacement implants. The patient also has a history of multiple surgeries on his lower extremities which could alter the patient¿s gait and add pressure to the components. It is not known to what extent, if any, these issues may have contributed to the patient problems reported. It is also not known to what extent, if any, component positioning may have contributed to the patient problems reported. From a medical perspective, based on the information available, it is not possible to determine if the complaint is product related. A complaint database search finds no additional reports against the provided product and lot combination. Based on the inability to determine a root cause, a need for corrective action is not indicated. In addition, the product code is an obsolete item and is not longer available to the customer. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
Manufacturer Narrative

The device fractured as a result of low-stress, high-cycle fatigue. There was no evidence of inclusions or other material defects that could have contributed to the crack initiation or propagation. The dhr review showed there were no manufacturing deviations or anomalies associated with any of the parts used in the arthroplasty. In addition to the components, there are numerous other factors that can affect the success of an ankle arthroplasty. In this case, the patient's weight and activity level, as well as the off-label use of implanting the components without cement, may have contributed to the fracture of the tibial component. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
Event Description

Update june 17, 2016 : device received and evaluated. Device history record review.

 
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Brand NameAGILITY TIBIAL SHELL SZ 4 LT
Type of DeviceANKLE IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46581
5743725905
MDR Report Key5483119
Report Number1818910-2016-14732
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/07/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/01/2004
Device Catalogue Number155524000
Device LOT NumberT66G41004
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/17/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/1999
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: 03/07/2016 Patient Sequence Number: 1
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