MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AGILITY POLY REG 1/2 CLMN SZ2; ANKLE IMPLANT

Catalog Number 155532010

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2014

Event Type  Injury  

Event Description

During a revision surgery reported separately, the new insert to be implanted was labeled as anterior on the posterior side.The surgeon put in the insert with the "anterior" etch facing up (anterior), and it wouldn't lock in.Knowing the design, he commented about the labeling being wrong and inserted the poly correctly, and it locked into place.

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.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device associated with this report was not returned.A provided photograph was examined by two depuy warsaw product development engineers.Based on the provided photograph and drawing specification, the etching was correct and the part was inserted incorrectly.Review of the device history records found no manufacturing deviations or rejections.A search of the complaint database found no additional reports for this part and lot number combination.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the 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.

• Brand Name: AGILITY POLY REG 1/2 CLMN SZ2
• 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: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3732949
• MDR Text Key: 4306922
• Report Number: 1818910-2014-16249
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2014

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: 155532010
• Device Lot Number: 148263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2014
• Initial Date FDA Received: 04/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2011
• 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: 61 YR
• Patient Weight: 118