MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150600007

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Business unit: depuy synthes ortho.Date j&j became aware: (b)(6) 2018 date of event: (b)(6) 2018.Name of reporter: (b)(6).Hospital name: (b)(6).Product name: attune knee.Product code: 8667326 and 8354299.Lot/batch/exp: d150600007c.Was the product being used in a clinical trial? no.Did the event happen during a procedure? no.Were you in the procedure at the time of the event? no.Event outcome/how was it managed? the patient had the attune knee implanted sometime ago in (b)(6) by mr (b)(6).The patient presented at (b)(6) and was seen by mr (b)(6).Numerous tests were complete and it was believed to be infected.The knee was revised today.Mr (b)(6) stated: ¿there was a pre-patella abscess.Doubtful intra-articular infection.Femur ¿ very well fixed.Tibia completely debonded from cement.Lifted off with (b)(6), underlying cement completely solid.I think this represents the published reports with regards to tibia debonding¿ no notes came with the patient hence the lack of lot and ref numbers.Was there any consequence to the patient due to the event? they had a knee revision due to either infection or tibial loosening or both.Was the surgery prolonged due to the event? no.Has the reporter facility indicated there may be legal action? no.Is the product available for return? no.Please give a detailed explanation of the event: the patient had the attune knee implanted sometime ago in (b)(6) by mr (b)(6).The patient presented at (b)(6) and was seen by mr (b)(6).Numerous tests were complete and it was believed to be infected.The knee was revised today at (b)(6) hospital.Mr (b)(6) stated ¿there was a pre-patella abscess.Doubtful intra-articular infection.Femur ¿ very well fixed.Tibia completely debonded from cement.Lifted off with (b)(6), underlying cement completely solid.I think this represents the published reports with regards to tibia debonding¿ no notes came with the patient hence the lack of lot and ref numbers.

Manufacturer Narrative

Pc-(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.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 7 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7582328
• MDR Text Key: 110479388
• Report Number: 1818910-2018-61642
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• 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: 8354299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Date Device Manufactured: 08/16/2016
• 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