MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM20X60MM; KNEE STEMS

Model Number	1513-20-060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/07/2021
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
The patient was revised to address disassociation of lps fusion spacer and knee contamination.It was reported that the implant came through his skin and became contaminated.All components were removed, a thorough i and d performed, and a new components were placed along with antibiotic beads.No surgical delay.Doi: (b)(6) 2021, dor: (b)(6) 2021, right knee.
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: added: b5.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 indicated that the patient had repeated revisions and component exchanges for infection involving depuy products.
Event or Problem Description
Additional information received indicated that the patient was being treated for infection.So, whether the infection had cleared since the date of surgery would be unlikely.However, this was not a new infection, it was a recurrent infection that has been being treated for years.The reason for exchanging the components was contamination due to the implant perforating his skin.
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: added: b5, h6 (clinical code).H6 clinical code: appropriate term / code not available (e2402) is used to capture infections (e19).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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATUNE PRESSFIT STR STEM20X60MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12263658
• Report Number: 1818910-2021-16768
• Device Sequence Number: 17160369
• Product Code: JWH
• UDI-Device Identifier: 10603295043782
• UDI-Public: 10603295043782
• 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: 2021
• 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,Followup
• Report Date (Section B): 07/07/2021

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: 1513-20-060
• Device Catalogue Number: 151320060
• Device Lot Number: J9677H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 08/13/2021; 08/30/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/09/2021; 08/19/2021; 08/31/2021
• 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: ATT REV SLV LPS FEM ADP +0.; ATT REV SLV LPS FEM ADP +10.; ATUN FEM SLV M/L 30MM FULL POR.; ATUN FEM SLV M/L 50MM FULL POR.; ATUNE PRESSFIT STR STEM20X60MM.; ATUNE PRESSFIT STR STEM20X60MM.; LPS INTERCALARY SEGMENT 55MM.; LPS SEGMENTAL COMPONENT 30MM.; LPS SEGMENTAL COMPONENT 85MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 100