MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE PRESSFIT STR STEM22X60MM; KNEE STEMS

Model Number 1513-22-060

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

Patient Problem Anemia (1706)

Event Date 02/15/2020

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 mild.Event is definitely not related to device and is definitely related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (left knee).Treatment: 2 x erythrocyte concentrate (transfusion 2 units packed red blood cells).

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: ATUNE PRESSFIT STR STEM22X60MM
• Type of Device: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11263896
• MDR Text Key: 229815849
• Report Number: 1818910-2021-02225
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295043843
• UDI-Public: 10603295043843
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1513-22-060
• Device Catalogue Number: 151322060
• Device Lot Number: J06R68
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 10MM; ATTUNE DIST FEM AUG SZ 8 8MM; ATTUNE DIST FEM AUG SZ 8 8MM; ATTUNE MEDIAL DOME PAT 41MM; ATUN FEM SLV M/L 45MM HALF POR; ATUN TIB SLV M/L 61MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM22X60MM; ATUNE REV RP TIB BASE SZ 8 CEM; COMPETITOR BONE CEMENT; ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 10MM; ATTUNE DIST FEM AUG SZ 8 8MM; ATTUNE DIST FEM AUG SZ 8 8MM; ATTUNE MEDIAL DOME PAT 41MM; ATUN FEM SLV M/L 45MM HALF POR; ATUN TIB SLV M/L 61MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM22X60MM; ATUNE REV RP TIB BASE SZ 8 CEM; COMPETITOR BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 154