MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN DEPUY AGILITY TIBIAL INSERT; ANKLE IMPLANT

Catalog Number UNK-EXTREM

Device Problem Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Date 07/07/2006

Event Type  Injury  

Event Description

Maude report (b)(4) submitted by patient states that he was revised on (b)(6) 2008 to address "tilting and slippage" of the talar component, causing pain and disfunction of gait and limited daily living activities.He also states that he was revised again on (b)(6) 2014 to address wound issues that were determined to be caused by a broken talar component.Authorization forms received (b)(6) 2014.Updated (b)(6) 2014.(b)(6) 2014 - the patient's medical records were received.Medical records were reviewed for mdr reportability.The medical records indicate the patient's talar component revised on (b)(6) 2008 had subsided.After being replaced the patient began to have problems with wound drainage and an abscess on their ankle.Due to a questionable infection the patient's plate and two screws were removed on (b)(6) 2011.The patient continued to have wound issues and questions of possible infection.On (b)(6) 2014 the patient went in for an i&d and bone biopsy.It was at this time it was determined the patient's talar implant had deviated medially.The patient underwent a revision on (b)(6) 2014 to address the talar component that had moved and was protruding out of the bone causing impingement of the nerve and tendon bundle.Upon revision the patient was found to have osteolysis in their ankle.There was never a confirmation the patient was infected.The complaint was updated on: (b)(6) 2014.

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.Udi: unknown.Depuy synthes has been informed that the catalog number and lot number are not available.

Manufacturer Narrative

Conclusion and justification status for mdr: update rec¿d 11/03/2014 - patient's medical records were received.The supplied patient medical records were reviewed by a depuy medical professional and the reported was confirmed.From a medical perspective, based on the information available, it is not possible to know if the complaint is product related.The implant and instrument sheet submitted within the reviewed medical records noted that the surgeon used depuy competitor instrumentation and not the depuy agility ankle arthroplasty instruments.It is not known to what extent, if any, this may have contributed to the reported patient problems but depuy products are not designed to work interchangeably with competing manufacturers¿ products.The patient is on several medications that affect bone weakness, loss or resorption, cause tendonitis, joint paint, bone pain and osteoporosis.It is not known to what extent, if any, these issues may have contributed to the patient problems reported.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to determine a root cause, a need for corrective action is 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

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.

Event Description

Update rec'd 11/03/2014 - patient's medical records were received.Medical records were reviewed for mdr reportability.There is no new information that would change the existing mdr decision.The complaint was updated on: 11/21/2014.

• Brand Name: UNKNOWN DEPUY AGILITY TIBIAL INSERT
• Type of Device: ANKLE IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4216767
• MDR Text Key: 5003176
• Report Number: 1818910-2014-30983
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2014

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: Health Professional
• Device Catalogue Number: UNK-EXTREM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 10/31/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/21/2014; 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Weight: 88