MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 32MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-032

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Medical records task received.After review of the medical records, office notes post revision reported pain, swelling, patella clunk and instability post revision.Treatment includes oral pain medication and physical therapy.Doi: (b)(6) 2020, doe: unknown, right knee.

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.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: ATTUNE MEDIAL DOME PAT 32MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12838192
• MDR Text Key: 280972070
• Report Number: 1818910-2021-25623
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056676
• UDI-Public: 10603295056676
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 1518-20-032
• Device Catalogue Number: 151820032
• Device Lot Number: 8534653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2017
• 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
• Treatment: ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 8MM; ATUN TIB SLV M/L 29MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic