MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 4 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-00-204

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

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 11/29/2021

Event Type  Injury  

Manufacturer Narrative

(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

Patient was revised due to surgeon thought that the patella was too thick causing some pain and low limited rom.The patella implant, tibial insert and femoral component were explanted.More patella bone was resected, the femur was downsized to a size 3 with a crs femoral component.The tibial base plates was left in situ.Patient had done her knee by a surgeon on (b)(6) 2020 at (b)(6).Doi: (b)(6) 2020 (femoral & patella), (b)(6) 2021 (tibial insert), dor: (b)(6)2021, 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: ATTUNE CR FEM RT SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 19380 ; 6107428552
• MDR Report Key: 12967596
• MDR Text Key: 281979474
• Report Number: 1818910-2021-27583
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041191
• UDI-Public: 10603295041191
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

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 Model Number: 1504-00-204
• Device Catalogue Number: 150400204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 12/30/2021
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM RT SZ 4 CEM.; ATTUNE MEDIAL DOME PAT 38MM.; UNK ATTUNE KNEE TIBIAL INSERT.; UNK ATTUNE KNEE TIBIAL TRAY.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female