MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-207

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Joint Laxity (4526)

Event Date 09/23/2020

Event Type  Injury  

Event Description

Patient received a right attune knee to treat osteoarthritis.The patella was resurfaced and depuy cement was utilized.There were no indicated intra-operative complications.Patient received a right knee revision to address pain, instability, flexion deformity, and tibial tray loosening at the cement to implant interface and bone to cement interface.Prior to revision the patient tested positive for nickel sensitivity and did have some patella baja.Due to the patella baja, the surgeon wanted to dislodge the joint line and did so with the use of augments.The tibial insert, tibial tray, and femoral component were revised.The patella component was retained.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.Doi: (b)(6) 2014, dor: (b)(6) 2020, right knee.

Manufacturer Narrative

(b)(4).Initial reporter 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

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: ATTUNE PS FEM RT SZ 7 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• 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: 13111812
• MDR Text Key: 282920540
• Report Number: 1818910-2021-28960
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041788
• UDI-Public: 10603295041788
• 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: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-207
• Device Catalogue Number: 150410207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• 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 FB TIB BASE SZ 7 CEM; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE PS FB INSRT SZ 7 5MM; ATTUNE PS FEM RT SZ 7 CEM; DEPUY CMW 1 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male