MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM22X60MM; KNEE STEMS

Model Number	1513-22-060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/12/2021
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
Revision of total knee replacement for infection.
Event or Problem Description
A.Date of implantation - (b)(6) 2021.B.Lot number: - attune crs femoral rt sz 7 cem (150440207) - lot # j8602j.- atune pressfit str stem24x60mm (151324060) - lot # j06r66.Refer to additional event information a-6001132 which has the usage from the primary surgery.C.Please confirm if the cement was manufactured by depuy? if yes, please provide the quantity, part and lot numbers of the cement.- unknown.D.Was surgery time extended? if yes, what was the duration of the delay? - as this was a revision procedure there was no extension to the surgical time.
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 and d6a.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.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: ATUNE PRESSFIT STR STEM22X60MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12261783
• Report Number: 1818910-2021-16742
• Device Sequence Number: 3590133
• Product Code: JWH
• UDI-Device Identifier: 10603295043843
• UDI-Public: 10603295043843
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2021

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: 1513-22-060
• Device Catalogue Number: 151322060
• Device Lot Number: J06R66
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/09/2021; 08/19/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/18/2021; 08/24/2021
• 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 CRS FEMORAL RT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 6MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE DIST FEM AUG SZ 7 8MM; ATTUNE POS FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 4MM; ATUN FEM SLV M/L 40MM FULL POR; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM22X60MM; ATUNE PRESSFIT STR STEM24X60MM; ATUNE REV RP TIB BASE SZ 6 CEM; ATTUNE CRS FEMORAL RT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 6MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE DIST FEM AUG SZ 7 8MM; ATTUNE POS FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 4MM; ATUN FEM SLV M/L 40MM FULL POR; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM22X60MM; ATUNE PRESSFIT STR STEM24X60MM; ATUNE REV RP TIB BASE SZ 6 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR