MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-00-124
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Joint Laxity (4526)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for second manipulations of knee under anesthesia: arthrofibrosis.Event is serious and is considered moderate.Event is not related to device and is related to procedure.Date of implantation: (b)(6) 2021, date of event (onset): (b)(6) 2021, (left knee).Treatment: knee manipulation.Pre-manipulation (in degrees): extension: 15.Hyperextension flexion: 70.Post-manipulation (in degrees): extension: 0.Hyperextension flexion: 120.
Additional Manufacturer Narrative
Product complaint # (b)(4).(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FEM LT SZ 4 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork LS11 8 DT; EI LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13266093
• Report Number: 1818910-2022-00960
• Device Sequence Number: 17333517
• Product Code: MBH
• UDI-Device Identifier: 10603295041139
• UDI-Public: 10603295041139
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1504-00-124
• Device Catalogue Number: 150400124
• Device Lot Number: 9721998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 96 KG