MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-510

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

Patient received a second right knee insert exchange and i& d to treat a postoperative hematoma.Upon entering the joint, the surgeon identified and evacuated an extensive periarticular hematoma.The surgeon notes the unknown medial retinacular suture was broken and repaired.There was no reported product problem with the revised tibial insert.The procedure was completed without complications.Doi: (b)(6) 2016, dor: (b)(6) 2019 (insert), 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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FB INSRT SZ 5 10MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11665656
• MDR Text Key: 245414644
• Report Number: 1818910-2021-07933
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295049968
• UDI-Public: 10603295049968
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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 Expiration Date: 10/31/2021
• Device Model Number: 1516-40-510
• Device Catalogue Number: 151640510
• Device Lot Number: H12389
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CEMENTED STEM 14X50MM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 5 CEM; ATUNE CRS FB TIB BASE SZ 5 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; UNK SUTURE; ATTUNE CEMENTED STEM 14X50MM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 5 CEM; ATUNE CRS FB TIB BASE SZ 5 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; UNK SUTURE
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR