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 Codes	Wound Dehiscence (1154); Fall (1848); Laceration(s) (1946); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 patient has previous dates of surgery as follows: (b)(6) 2019 (primary implantation), (b)(6) 2020 (first revision), (b)(6) 2021 (poly insert revision) and (b)(6) 2021 (third revision.Hardware was placed and or exchanged on these dates.Der's were submitted each time.Patient had returned home and was doing well.Patient has a bad fall and lacerated his knee transversely.Patient was treated at another facility.After a few weeks patient was brought to the er by his daughter were patient was seen and had an open wound.Surgeon believed there was gross contamination of the joint and chose to remove all components.A new spacer was placed and depuy cement was used but it is hospital owned so do not have part or lot information.Doi: (b)(6) 2019 (primary implantation), (b)(6) 2020 (first revision), (b)(6) 2021 (poly insert revision), (b)(6) 2021 (third revision).Dor: (b)(6) 2021, right knee.This report captures the event and products involved for (b)(6) 2021.
Event or Problem Description
Additional information was received stating that depuy synthes product was in the patient.It was removed subsequent the noted injury.They do not believe there to have been any product deficit, however after having a open would over a joint replacement, the surgeon felt it was necessary to remove.Everything was removed.
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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).Where the lot code was provided, 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
• MDR Report Key: 11437168
• Report Number: 1818910-2021-04620
• Device Sequence Number: 3976728
• Product Code: NJL
• UDI-Device Identifier: 10603295419624
• UDI-Public: 10603295419624
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2021

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: J68W64
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/09/2021; 03/31/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/24/2021; 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE REV LPS INSRT XXSM 12MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; LPS DISTAL FEM COMP XXSM RT; LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 30MM; LPS XX-SM HINGE PIN; UNIVERSAL FEM SLV DIS POR 31MM; UNIVERSAL STEM 75X16MM FLUTED; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR