MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB SLV M/L 29MM HALF POR; KNEE TIBIAL TRAY ACCESSORY

Model Number	1511-11-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/25/2021
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
Clinical adverse event received for aspiration of study knee - as a result of raised crp and infection - confirmation of loosening tibial component? unconfirmed currently.Event is serious and is considered severe.Event is possibly related to device and is probably related to procedure.Date of implantation: (b)(6) 2018; date of event (onset): (b)(6) 2021 (right knee).Treatment: arthroscopy, arthroscopic biopsies to confirm infected total knee; aspiration/drainage.
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.

• Brand Name: ATUN TIB SLV M/L 29MM HALF POR
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: amy hendrickson ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 5743674841
• MDR Report Key: 13939587
• Report Number: 1818910-2022-05739
• Device Sequence Number: 6468276
• Product Code: NJL
• UDI-Device Identifier: 10603295419624
• UDI-Public: 10603295419624
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 1511-11-101
• Device Catalogue Number: 151111101
• Device Lot Number: HG4734
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• 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: ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS RP INSRT SZ 4 12MM; ATTUNE REV POST FEM AUG SZ 4 4MM; ATTUNE REV TIB BASE ROTATING PTFORM SZ 4 CEM; ATTUNE REV TIB SLV POR PART COATED 29 MM; ATTUNE REVISION CEMENTED STEM 16 MM X 80 MM; ATTUNE REVISION CRS FEMORAL SIZE 4 CEM; PALACOS R+G 2X40 BONE CEMENT; PALACOS R+G 2X40 BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 89 KG