MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB AUG LM/RL SZ 5/6 10MM; KNEE TIBIAL TRAY ACCESSORY

Model Number	1523-05-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	12/20/2021
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
It was reported that this patient's previously revised knee was revised a second time due to pain and instability.The patient's attune revision knee components were removed and replaced by an s-rom noiles hinged femur, an lps hinged rp insert, and a sigma revision mbt tibial tray.Depuy smartset medium viscosity bone cement would have been used in the prior revision procedure, since the hospital only stocks smartset cement.The product codes and lot numbers for the cement is not available, since the cement used was hospital inventory ordered directly from depuy.Doi: (b)(6) 2020.Dor: (b)(6) 2021.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.

• Brand Name: ATUN TIB AUG LM/RL SZ 5/6 10MM
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• 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: 13170681
• Report Number: 1818910-2022-00236
• Device Sequence Number: 4464937
• Product Code: JWH
• UDI-Device Identifier: 10603295057604
• UDI-Public: 10603295057604
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 01/05/2022

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: 1523-05-102
• Device Catalogue Number: 152305102
• Device Lot Number: J4111D
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2019
• 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 CEMENTED STEM 14X30MM.; ATTUNE CRS FEMORAL RT SZ 5 CEM.; ATTUNE CRS RP INSRT SZ 5 20MM.; ATTUNE DIST FEM AUG SZ 5 4MM.; ATTUNE DIST FEM AUG SZ 5 4MM.; ATTUNE POS FEM AUG SZ 5 8MM.; ATTUNE POS FEM AUG SZ 5 8MM.; ATUN PRESSFIT STR STEM12X110MM.; ATUN TIB AUG LM/RL SZ 5/6 10MM.; ATUN TIB AUG RM/LL SZ 5/6 10MM.; ATUN TIB SLV M/L 29MM FULL POR.; ATUNE REV RP TIB BASE SZ 5 CEM.; CEMENT RESTRICTOR SIZE 4.; UNK CEMENT SMARTSET MV.
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male