MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 7 CEM; KNEE FEMORAL

Model Number 1504-40-107

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.(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).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.  h10 additional narrative: added: h6.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.  corrected: h6 (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).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 CRS FEMORAL LT SZ 7 CEM
• Type of Device: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9447136
• MDR Text Key: 185481561
• Report Number: 1818910-2019-122190
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042204
• UDI-Public: 10603295042204
• 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
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-40-107
• Device Catalogue Number: 150440107
• Device Lot Number: HH2706
• 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.; ATTUN REV OFFST STM ADPTR 4MM.; ATTUNE CRS RP INSRT SZ 7 6MM.; ATTUNE DIST FEM AUG SZ 7 4MM.; 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 REV RP TIB BASE SZ 6 CEM.; SMARTSET GMV 40G US EO.; SMARTSET GMV 40G US EO.; UNK ATTUNE KNEE PATELLA.
• Patient Age: 64 YR
• Patient Weight: 98