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

Catalog Number 140404050

Device Problems Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)

Patient Problems Edema (1820); Pain (1994)

Event Date 04/12/2012

Event Type  Injury  

Event Description

Litigation alleges the patient suffers from pain, swelling and loosening.Litigation alleges "the arthroplasty was loose with little bone left between the prosthetic talar component" and the patient's subtalar joint.

Manufacturer Narrative

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

Manufacturer Narrative

The device associated with this report was not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot code required was not provided.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Update: manufacturing facility from (b)(4) to (b)(4).This complaint is still in investigation, depuy will send a final medwatch upon completion of investigation.

Manufacturer Narrative

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

Event Description

Update 5/14/15 medical records received.After review of the medical records for mdr reportability, clinic note from (b)(6) 2012 indicated the talus component had subsided within the talus.Records indicate the need for a second revision, but implants placed (b)(6) 2012 were not depuy products.The complaint was updated on:6/1/2015.

Manufacturer Narrative

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

Event Description

Update rec'd 6/27/2014- medical records received.Part/lot was provided.After review of the medical records the revision operative note indicated both the tibial and talar compents were loose and the tibial insert was dissociated from the tibial component.There is no new additional information that would affect the existing mdr decision.

Manufacturer Narrative

Update: 6 feb 2015.A complaint database search finds no other reported incidents against the provided product and lot combinations.Medical records were reviewed and with the limited amount of information that was provided, it cannot be determined that the complaint is product related.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

Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number is not available.Conclusion and justification status for mdr: update january 18, 2016: received patient x-rays on (b)(6) 2015.Review of the supplied patient x-rays revealed evidence suggesting there is osteolysis adjacent to the tibial implant at the medial and lateral malleoli and inferior to the talar component and the talar component has subsided.However, neither the osteolysis or subsidence can be confirmed without serial radiographs to use for comparison.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.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 supplied radiographs were of very poor quality.The only discernible finding was lucency adjacent to the talar component on the lateral view.Review of the newly provided medical records identified no other new findings to report since the previous medical record review dated 26 jan 2015.The investigation could not verify or identify any product contribution to the reported event with the new information provided.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 3/4/16 -medical records received.After review of the medical records for mdr reportability, there is no new additional information that would affect the existing investigation.The complaint was updated on: mar 17, 2016.

• Brand Name: AGILITY LP TALAR SZ 4LT
• Type of Device: ANKLE IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 3803164
• MDR Text Key: 20460599
• Report Number: 1818910-2014-18470
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK053569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 140404050
• Device Lot Number: BA8CRA000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 05/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/13/2014; 07/01/2014; 07/14/2014; 02/26/2015; 06/09/2015; 01/21/2016; 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2007
• 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: 55 YR