MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 4 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151630412

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Received medical records on 05/18/2018.Records reported that the patient was revised to address right knee pain, mid-flexion instability, and tibial base plate and femur implant loosening.Surgeon indicated that the tibia completely debonded from the cement mantle.The femur was partially debonded, but not to the degree of the tibia.The tibial insert was found to be rotated 180 degrees from normal orientation.There was significant wear on the posterior aspect of the polyethylene tibia insert.The patella was well-fixed.Tibia, femur, patella, and insert were all revised.Doi: (b)(6) 2016; 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.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 RP INSRT SZ 4 12MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7604789
• MDR Text Key: 111150387
• Report Number: 1818910-2018-62270
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295047674
• UDI-Public: 10603295047674
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 151630412
• Device Lot Number: 8035928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2018
• Date Device Manufactured: 12/12/2014
• 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: 61 YR