MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 4 8MM; KNEE FEMORAL ACCESSORY

Model Number 1547-04-002

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

Patient Problem Anemia (1706)

Event Date 02/25/2021

Event Type  Injury  

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

Clinical adverse event received for post-operative anemia.Event is not serious and is considered moderate.Event is definitely not related to device and definitely related to procedure.Date of implant: (b)(6) 2021, date of event: (b)(6) 2021, (left knee).Treatment: blood transfusion.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE DIST FEM AUG SZ 4 8MM
• Type of Device: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12234488
• MDR Text Key: 264985235
• Report Number: 1818910-2021-16169
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295382720
• UDI-Public: 10603295382720
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

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: 1547-04-002
• Device Catalogue Number: 154704002
• Device Lot Number: J2153U
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUN REV OFFST STM ADPTR 6MM; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FB INSRT SZ 4 12MM; ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE DIST FEM AUG SZ 4 8MM; ATUNE CRS FB TIB BASE SZ 3 CEM; ATUNE PRESSFIT STR STEM10X60MM; COMPETITOR CEMENT(66017750/95904875); HERAEUS MEDICAL GMBH PALACOS CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 90