MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 7 4MM; KNEE FEMORAL ACCESSORY

Model Number 1547-07-001

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 09/14/2018

Event Type  Injury  

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.Concomitant medical products: atune rev rp tib base sz 6 cem knee tibial tray component; attune crs femoral lt sz 7 cem knee femur component; attune crs rp insrt sz 7 6mm knee tibial insert component; unknown knee patella component; smartset gmv 40g us eo bone cement; atun tib slv m/l 37mm full por knee tibial tray component; atune pressfit str stem12x60mm knee tibial tray component; attune pos fem aug sz 7 4mm knee femur component x 2; attune dist fem aug sz 7 4mm knee femur component x 2; attun rev offst stm adptr 4mm knee femur component; attune pressfit str stem16x60mm knee femur component.(b)(4).

Event Description

Subject id: (b)(6).Clinical adverse event received for infected left total knee arthroplasty.Event is serious and is considered moderate in severity.Event is not related to device and is possibly related to procedure.Doi: (b)(6) 2018; doe:(b)(6) 2018.Patient hospitalized for treatment, event is ongoing; left knee.

Manufacturer Narrative

Product complaint #: (b)(4).This medwatch report was created in error.There was no reportable product deficiency.Please disregard the previously reported content.

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 Description

The new information provided states that the infection adverse event was treated with an irrigation & debridement, with revision of components, as well as iv medications.It should be noted that the implant procedure for these products took place on (b)(6) 2018, which appears to have been the re-implantation of products, following explantation of antibiotic spacer for deep infection.There is no information available with regard to the original knee infection, date of primary and first revision, and products involved.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  corrected: (no code available (3191) is used to capture the device revision or replacement).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

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.

• Brand Name: ATTUNE DIST FEM AUG SZ 7 4MM
• Type of Device: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7960178
• MDR Text Key: 123515640
• Report Number: 1818910-2018-72319
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295382812
• UDI-Public: 10603295382812
• Combination Product (y/n): N
• PMA/PMN Number: K160700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1547-07-001
• Device Catalogue Number: 154707001
• Device Lot Number: HW5735
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FEMORAL LT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 6MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 4MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 6 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; UNK ATTUNE KNEE PATELLA
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98