MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AGILITY TIBIAL +2 INSERT SZ 3; AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL

Catalog Number 155533020

Device Problem Naturally Worn (2988)

Patient Problems Loss of Range of Motion (2032); No Code Available (3191)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient had reduced range of motion.The insert was revised/exchanged.Limited poly wear.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AGILITY TIBIAL +2 INSERT SZ 3
• Type of Device: AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 7996020
• MDR Text Key: 124719006
• Report Number: 1818910-2018-73270
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10603295058717
• UDI-Public: 10603295058717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 155533020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2018
• 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: 55 YR
• Patient Weight: 119