MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CEMENTED STEM 16X80MM; KNEE STEMS

Model Number	1512-16-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)
Date of Event	10/22/2020
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
Clinical notification received for revision of left total knee to address infection as a consequence of periprosthetic joint infection; septic multi organ failure due to acute periprosthetic joint infection of the left knee and empyema of the right knee and left shoulder.Date of implantation: (b)(6) 2019, date of revision: (b)(6) 2020, (left knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: product description: attune cemented stem 16x80mm, product code: 151216080, and lot number: hy2694.Quantity manufactured: 12, date of manufacture: 6/20/2018, any anomalies or deviations identified in dhr: na, expiry date: 5/31/2028, and ifu reference: (b)(4).

• Brand Name: ATTUNE CEMENTED STEM 16X80MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10831724
• Report Number: 1818910-2020-24510
• Device Sequence Number: 1720606
• Product Code: JWH
• UDI-Device Identifier: 10603295043010
• UDI-Public: 10603295043010
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: 1512-16-080
• Device Catalogue Number: 151216080
• Device Lot Number: HY2694
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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 CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 12MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE MEDIAL DOME PAT 41MM; ATUNE REV RP TIB BASE SZ 8 CEM; REFOBACIN CEMENT:47115003963/814CA09175; REFOBACIN CEMENT:47115003963/814CA09175; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 12MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE MEDIAL DOME PAT 41MM; ATUNE REV RP TIB BASE SZ 8 CEM; REFOBACIN CEMENT:47115003963/814CA09175; REFOBACIN CEMENT:47115003963/814CA09175
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 87