MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150600005

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Der states that attune tibial tray was loosened, surgeon was able to extract the implanted attune tibia and pick away the cement and revise the tibia to an attune tibial revision.The femur was left in place.Loosening occurred from cement to implant interface.Cement manufacture is of competitor.(b)(6) 2015.(b)(6) 2017.Right knee.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The received device was forwarded to commercialized product development for evaluation.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A definitive root cause of the reported event is unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE FB TIB BASE SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7150778
• MDR Text Key: 95915568
• Report Number: 1818910-2017-52606
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042396
• UDI-Public: 10603295042396
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150600005
• Device Lot Number: 8063988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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: 42 YR