MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK KNEE FEMORAL ATTUNE PS; FEMORAL

Catalog Number UNK KNEE FEMORAL ATTUNE PS

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

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 01/31/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # : (b)(4).The initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised due to pain, instability and loosening of the tibial component at the cement to implant interface.Unknown cement was used.Doi: unknown, dor: (b)(6) 2022, affected side: right knee.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK KNEE FEMORAL ATTUNE PS
• Type of Device: FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13506670
• MDR Text Key: 286725093
• Report Number: 1818910-2022-02682
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL ATTUNE PS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 PS FB INSRT SZ 5 10MM.; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN).; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN).; UNK KNEE FEMORAL ATTUNE PS.; UNK KNEE TIBIAL TRAY ATTUNE FB.; UNK KNEE TIBIAL TRAY ATTUNE FB.; UNKNOWN ATTUNE KNEE TIBIAL INSERT.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female