MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL RT SZ 9 CEM; KNEE FEMORAL

Model Number 1504-40-209

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anemia (1706)

Event Date 09/10/2020

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.

Event Description

Clinical adverse event received for anemia- post op iron substitution.Event is not serious and is considered mild.Event is definitely not related to both device and is possibly related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (right knee).Treatment: injected medication (unspecified).

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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CRS FEMORAL RT SZ 9 CEM
• Type of Device: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10924724
• MDR Text Key: 218920166
• Report Number: 1818910-2020-25746
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042327
• UDI-Public: 10603295042327
• Combination Product (y/n): N
• PMA/PMN Number: K160700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

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
• Device Operator: Health Professional
• Device Model Number: 1504-40-209
• Device Catalogue Number: 150440209
• Device Lot Number: J3829Y
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FB INSRT SZ 9 6MM; ATTUNE CRS FEMORAL RT SZ 9 CEM; ATTUNE DIST FEM AUG SZ 9 4MM; ATTUNE DIST FEM AUG SZ 9 4MM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE POS FEM AUG SZ 9 4MM; ATTUNE POS FEM AUG SZ 9 8MM; ATUN CRS FB TIB BASE SZ 10 CEM; ATUN FEM SLV M/L 40MM HALF POR; ATUN PRESSFIT STR STEM20X110MM; HERAEUS MEDICAL - COPAL G+C BONE CEMENT; ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FB INSRT SZ 9 6MM; ATTUNE CRS FEMORAL RT SZ 9 CEM; ATTUNE DIST FEM AUG SZ 9 4MM; ATTUNE DIST FEM AUG SZ 9 4MM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE POS FEM AUG SZ 9 4MM; ATTUNE POS FEM AUG SZ 9 8MM; ATUN CRS FB TIB BASE SZ 10 CEM; ATUN FEM SLV M/L 40MM HALF POR; ATUN PRESSFIT STR STEM20X110MM; HERAEUS MEDICAL - COPAL G+C BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 90