MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE MEDIAL DOME PAT 41MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number 151820041

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

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

Event Date 02/25/2019

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.(b)(4).

Event Description

The patient was revised to address pain and loosening of the unknown component at cement to implant interface.Unknown cement was used.It was also reported that rtk: attune rp/ps cemented with poly patella and the surgeon elected to surgically open the joint and evaluate the issues, all components were loose and a full revision was performed.Doi: unknown; dor: (b)(6) 2019, 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 at this time.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 MEDIAL DOME PAT 41MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8424988
• MDR Text Key: 138936663
• Report Number: 1818910-2019-87434
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056706
• UDI-Public: 10603295056706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 151820041
• Device Lot Number: 7296496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• 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: 81 YR