MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 8 10MM; KNEE TIBIAL INSERT

Model Number	1517-10-810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Date of Event	07/10/2020
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 pain and loosening of femoral component at cement to bone interface.An unknown cement was used.The plan was revision of the femoral component, but cultures taken intra-op turned out positive for infection.All components were revised and replaced with antibiotic spacer.Doi: (b)(6) 2019, dor: (b)(6) 2020, left knee.
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.

• Brand Name: ATTUNE CRS RP INSRT SZ 8 10MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10299999
• Report Number: 1818910-2020-16306
• Device Sequence Number: 10883853
• Product Code: JWH
• UDI-Device Identifier: 10603295056256
• UDI-Public: 10603295056256
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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: 1517-10-810
• Device Catalogue Number: 151710810
• Device Lot Number: 8807012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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 LT SZ 8 CEM.; ATTUNE CRS RP INSRT SZ 8 10MM.; ATUN FEM SLV M/L 35MM FULL POR.; ATUN TIB SLV M/L 37MM FULL POR.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE PRESSFIT STR STEM18X60MM.; ATUNE REV RP TIB BASE SZ 7 CEM.; ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 10MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM18X60MM; ATUNE REV RP TIB BASE SZ 7 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR