MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 6 NAR CEM ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-226

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

Patient Problem Joint Laxity (4526)

Event Date 10/25/2021

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.

Event Description

Patients was revised due to laxity. The original knee was done on (b)(6) 2017. On (b)(6) 2019, a revision was performed for tibial loosening where the femoral component and patella component were retained. An mdr was filled out on this date but do not have the complaint number. For this procedure today, only the femoral component was revised to a more constrained knee. Doi: (b)(6) 2017 dor: (b)(6) 2021 right knee.

• Brand Name: ATTUNE PS FEM RT SZ 6 NAR CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12780984
• Report Number: 1818910-2021-24705
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041856
• UDI-Public: 10603295041856
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1504-10-226
• Device Catalogue Number: 150410226
• Device Lot Number: H62087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Treatment(s): ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 6 NAR CEM; ATTUNE PS RP INSRT SZ 6 8MM; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 29MM FULL POR; ATUNE REV RP TIB BASE SZ 5 CEM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN)
• Patient Outcome(s): Required Intervention