MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 35MM HALF POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-103
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	07/14/2020
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
It was reported that patient total knee had been revised on (b)(6) 2019 for infection.Patient had never followed up after surgery and came back to see with a painful knee.Surgeon worked her up and found out patient had another infection and decided to removed knee implants.Surgeon removed all the implants with no problems and did a washout of the knee.Replaced with an antibiotic cement spacer.Surgeon had no difficulties removing the implants and time was not extended for any reason.Doi: (b)(6) 2019 dor: (b)(6) 2020 right knee.
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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATUN FEM SLV M/L 35MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10312193
• Report Number: 1818910-2020-16626
• Device Sequence Number: 16411971
• Product Code: JWH
• UDI-Device Identifier: 10603295436508
• UDI-Public: 10603295436508
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/14/2020

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: 1511-01-103
• Device Catalogue Number: 151101103
• Device Lot Number: J4224D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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 RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 6MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 6 4MM; ATTUNE POS FEM AUG SZ 6 4MM; ATUN FEM SLV M/L 35MM HALF POR; ATUN TIB SLV M/L 37MM HALF POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE PRESSFIT STR STEM20X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 6MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 6 4MM; ATTUNE POS FEM AUG SZ 6 4MM; ATUN FEM SLV M/L 35MM HALF POR; ATUN TIB SLV M/L 37MM HALF POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE PRESSFIT STR STEM20X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR