MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSERT SZ 4 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-407
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).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.No device(s) associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A complaint database search did find additional related reports against the provided product code and lot number combination(s) for adhesion.Since allegation is not related to manufacturing, mre will not be performed.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was 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.Device history batch: null.Device history review: null.

• Brand Name: ATTUNE CR FB INSERT SZ 4 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13266091
• Report Number: 1818910-2022-00959
• Device Sequence Number: 14642730
• Product Code: JWH
• UDI-Device Identifier: 10603295045540
• UDI-Public: 10603295045540
• 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 Expiration Date: 01/31/2026
• Device Model Number: 1516-20-407
• Device Catalogue Number: 151620407
• Device Lot Number: JA8685
• 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: 02/24/2021
• 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