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

Catalog Number 150600007

Device Problems Loss of or Failure to Bond (1068); Patient-Device Incompatibility (2682)

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

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received ad 17 june 2019.The patient underwent a left knee revision due to pain, over-sized tibial tray, and tibial tray loosening at the cement to implant interface.The femoral component and patella component were not revised.Depuy cement was used during the primary operation.Doi: (b)(6) 2016, dor: (b)(6) 2017.Left knee.

Manufacturer Narrative

Product complaint # (b)(4).Mfr#1818910-2019-113874 is being retracted since it was found to be a duplicate of mfr# 1818910-2017-50770.Mfr# 1818910-2017-50770 will be kept for investigation purposes.

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.If information is obtained that was not available for the initial medwatch, a follow-up 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 co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9273458
• MDR Text Key: 180818994
• Report Number: 1818910-2019-113874
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042419
• UDI-Public: 10603295042419
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2019

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: 8251706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 12/06/2019; 12/06/2019
• Supplement Dates FDA Received: 12/06/2019; 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• 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
• Patient Age: 64 YR