MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB SLV M/L 53MM FULL POR; KNEE TIBIAL TRAY ACCESSORY

Model Number	1511-11-204
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Revision of depuy tkr components for implant loosening.Left knee.Lot numbers not sourced.Implants discarded.Doi: (b)(6) 2009, dor (12th): (b)(6) 2021, dor (13th): (b)(6) 2022.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: 1.Please clarify the loosening interface of the tibial component.Was it at the bone to cement or cement to implant interface? my understanding is that the bone to implant interface was loose in relation to the uncemented sleeve and stem.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: 1.Please advise which component/s were loose? all tibial components.No bony ingrowth on the tibial sleeve.2.Did the surgeon identify the cause of the loosening? no.3.Per our records, this is the patient's 13th revision.Most of the patient's revisions so far have been due to suspected infection (including the last two revisions in 2021 which were 1st and 2nd stage revisions for confirmed infection).Is there a possibility that the loosening was related to infection? was any testing performed to check? possibly.Several tissue samples were collected and sent for testing, but none have returned positive results for infection.4.Was the cement used depuy manufactured? if so, please provide product codes/lot numbers/quantity used.No.Heraeus palacos was used.5.Was there any alleged deficiency to the other explanted devices? if yes, please provide details.No, femoral components were removed and replaced for access purposes only.

• Brand Name: ATUN TIB SLV M/L 53MM FULL POR
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15650235
• Report Number: 1818910-2022-21055
• Device Sequence Number: 19409017
• Product Code: NJL
• UDI-Device Identifier: 10603295436584
• UDI-Public: 10603295436584
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1511-11-204
• Device Catalogue Number: 151111204
• Device Lot Number: J7921N
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 11/08/2022; 11/30/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/08/2022; 11/24/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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 REV LPS INSRT XSM 12MM; ATUN PRESSFIT STR STEM18X110MM; ATUNE REV RP TIB BASE SZ 7 CEM; LPS DISTAL FEM COMP XSM LT; LPS FEM TO SLEEVE ADAPTER +0; LPS SEGMENTAL COMPONENT 40MM; P.F.C.* TIB STM EXT 4/5/6 60MM; PALACOS BONE CEMENT; UNIVERSAL FEM SLV FUL POR 46MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male