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

Catalog Number 151620706

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: evaluation of the returned device identified polyethylene wear.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient experienced pain and poor function.The tibial tray was loose.

Manufacturer Narrative

Investigation summary: evaluation of the returned device identified polyethylene wear.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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 CR FB INSRT SZ 7 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM ¿ 1219655 ; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7975106
• MDR Text Key: 124010558
• Report Number: 1818910-2018-72769
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295045892
• UDI-Public: 10603295045892
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 151620706
• Device Lot Number: 591001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• 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: 71 YR