MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150600007

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Pain (1994); No Code Available (3191)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).Initial reporter occupation: lawyer.(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

The patient underwent a right knee revision due to pain, adhesions, and tibial tray loosening at an unknown interface.The surgeon noted the anterior flange of the femoral component was slightly off of the anterior femur which allowed good access to disrupt the cement mantle.Depuy cement was used during the primary operation.Doi: (b)(6) 2015, dor: (b)(6) 2018, right knee.

Manufacturer Narrative

This is a duplicate report of orig mfr.(1818910-2018-62276).Original mfr-(1818910-2018-62276) will be kept for investigational purposes.

• Brand Name: ATTUNE FB TIB BASE SZ 7 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8966713
• MDR Text Key: 156662701
• Report Number: 1818910-2019-103217
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042419
• UDI-Public: 10603295042419
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150600007
• Device Lot Number: 8003863
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE PS FB INSRT SZ 8 8MM; ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE PS FB INSRT SZ 8 8MM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR