MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE REV RP TIB BASE SZ 2 CEM; KNEE TIBIAL TRAY

Model Number	1506-60-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/09/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient remains infected.All components were removed and a spacer was fashioned utilizing lps components.Cement was depuy 2 with gent but no quantity or lot information is available as it is hospital owned inventory.It was also reported that tibial and femoral components were loose at the bone to implant interface.Doi: (b)(6) 2022; dor: (b)(6) 2022; affected side: right knee.
Additional 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 or Problem Description
Additional information received: components did not ingrown because of infection.So, technically they were not ¿loose¿ but were not fixed as would have been expected in a non infected joint.The cement was well fixed to bone and the tray.However, once this interface was disrupted, the tibial components were removed easily as the sleeve had not ingrown.Once assembled the 3 tibial components make up the tibia implant imo.

• Brand Name: ATUNE REV RP TIB BASE SZ 2 CEM
• Common Device Name: 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: 14207955
• Report Number: 1818910-2022-07549
• Device Sequence Number: 19293080
• Product Code: JWH
• UDI-Device Identifier: 10603295042860
• UDI-Public: 10603295042860
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1506-60-002
• Device Catalogue Number: 150660002
• Device Lot Number: 9751825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATT REV SLV LPS FEM ADP +5.; ATTUNE REV LPS INSRT XXSM 12MM.; ATUN FEM SLV M/L 30MM FULL POR.; ATUN TIB SLV M/L 37MM FULL POR.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE REV RP TIB BASE SZ 2 CEM.; CONTROL CABLE W/CABLE SLEEVE.; LPS DISTAL FEM COMP XXSM RT.; UNK CEMENT GENTAMICIN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 63 KG