MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE REV RP TIB BASE SZ 5 CEM; KNEE TIBIAL TRAY

Model Number 1506-60-005

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

Patient Problems Pain (1994); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)

Event Date 01/17/2022

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

Clinical notification received for revision due to instability.Date of implant: (b)(6) 2021.Date of revision: (b)(6) 2022.(right knee).

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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Event Description

Primary operative notes on (b)(6) 2021, indicate the patient received a right total knee replacement due to right knee end stage arthritis and previous multiligamentous knee injury.The surgery was completed without indication of complication by the surgeon.Revision operative notes on (b)(6) 2022, indicate the patient received a right total knee revision due to having a twisting episode with a tearing feeling in her knee on the medial side, dislocation of the poly insert, pain and instability.Intra-operatively it was noted that polyethylene had dislocated and rotated 90 degrees.The insert and femoral components were revised to a hinged prosthesis.It was noted that the patient¿s femoral bone was brittle in appearance, therefore the surgeon applied 2 cables as a preventative measure ¿ no indication of fracture.The surgery was completed without indication of complication by the surgeon.

• Brand Name: ATUNE REV RP TIB BASE SZ 5 CEM
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14239731
• MDR Text Key: 290368470
• Report Number: 1818910-2022-07782
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042891
• UDI-Public: 10603295042891
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1506-60-005
• Device Catalogue Number: 150660005
• Device Lot Number: 9792180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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 CEMENTED STEM 14X50MM.; ATTUNE CRS FEMORAL RT SZ 5 CEM.; ATTUNE CRS RP INSRT SZ 5 6MM.; ATTUNE MEDIAL DOME PAT 38MM.; SMARTSET GMV 40G US EO.; SMARTSET GMV 40G US EO.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic