MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 4 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-10-004

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Date 08/21/2020

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

We revised an attune primary implant.The original attune was implanted on (b)(6) 2018 (approximate date only entered below).It was revised today ((b)(6) 2020).The reason for revision was aseptic tibial loosening.The implant was loose at the cement/implant interface.The femur was well secured and wasn't in need of revising.This was revised just so we could use a revision construct all the way through.Removed: size 5 attune cr femur, size 5 insert, size 3 tibial base.

Manufacturer Narrative

Product complaint # (b)(4).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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: a1, b5, h6 (patient).Corrected: d6.Patient code: no code available (3191) is used to capture insufficient information.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Affected side: right knee.

• Brand Name: ATTUNE RP TIB BASE SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10506769
• MDR Text Key: 206099037
• Report Number: 1818910-2020-19597
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042587
• UDI-Public: 10603295042587
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-10-004
• Device Catalogue Number: 150610004
• Device Lot Number: 8560056
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE CR RP INSRT SZ 6 5MM; ATTUNE RP TIB BASE SZ 3 CEM; PALACOS R+G 1X40; PALACOS R+G 1X40; ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE CR RP INSRT SZ 6 5MM; ATTUNE RP TIB BASE SZ 3 CEM; PALACOS R+G 1X40; PALACOS R+G 1X40
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR