MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-10-041

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

Patient Problem Muscular Rigidity (1968)

Event Date 11/15/2019

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 right knee stiffness.Event is serious and is considered moderate.Event is possibly related to device and is definitely related to procedure.Date of implantation: (b)(6) 2019, date of event (onset): (b)(6) 2019, (right knee).Treatment: surgical intervention - manipulation of right knee under anesthesia.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 MEDIAL ANAT PAT 41MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11633688
• MDR Text Key: 244401406
• Report Number: 1818910-2021-07421
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056652
• UDI-Public: 10603295056652
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1518-10-041
• Device Catalogue Number: 151810041
• Device Lot Number: 8894960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 8MM; ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE POS FEM AUG SZ 6 4MM; ATUN FEM SLV M/L 35MM HALF POR; ATUN TIB SLV M/L 29MM FULL POR; ATUNE PRESSFIT STR STEM10X60MM; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 6 CEM; COPAL BONE CEMENT; COPAL BONE CEMENT; ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 8MM; ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE POS FEM AUG SZ 6 4MM; ATUN FEM SLV M/L 35MM HALF POR; ATUN TIB SLV M/L 29MM FULL POR; ATUNE PRESSFIT STR STEM10X60MM; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 6 CEM; COPAL BONE CEMENT; COPAL BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 75