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

Catalog Number 155524000

Device Problems Break (1069); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

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.

• Brand Name: AGILITY TIBIAL SHELL SZ 4 LT
• Type of Device: ANKLE 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 Key: 5483119
• MDR Text Key: 39752196
• Report Number: 1818910-2016-14732
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK920802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2004
• Device Catalogue Number: 155524000
• Device Lot Number: T66G41004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/1999
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 95