MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 6 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-607

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/24/2018

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

Patient was revised to address instability.It was also stated that the patient was seeking legal recourse against the (b)(6).Doi: unknown.Dor: (b)(6) 2018; right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATTUNE PS FB INSRT SZ 6 7MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9416219
• MDR Text Key: 169238901
• Report Number: 1818910-2019-120677
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050087
• UDI-Public: 10603295050087
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1516-40-607
• Device Catalogue Number: 151640607
• Device Lot Number: 328662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 7 CEM.; ATTUNE PS FEM RT SZ 6 CEM.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE PS FEM RT SZ 6 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR