MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-706
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Primary operative notes (b)(6) 2016 indicate the patient received a left total knee replacement due to severe degenerative joint disease and flexion contracture.The patella was resurfaced, and depuy cement was utilized x2.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2019 indicate the patient received a left total knee revision due to pain, decreased range of motion.Initially, manipulation under anesthesia and joint aspiration was performed that provided temporary relief, it was then determined a revision was needed.Upon entering the joint, significant scar tissue was encountered and removed.The femoral and patella components were not revised, no indication of deficiency.The tibial component was subsided and loose at the cement to implant interface.Tibial insert revised without indication of deficiency.The surgery was completed without indication of complication by the surgeon.Doi: (b)(6) 2016 dor: (b)(6) 2019 left knee.
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.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 CR FB INSRT SZ 7 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11738446
• Report Number: 1818910-2021-09055
• Device Sequence Number: 14411115
• Product Code: JWH
• UDI-Device Identifier: 10603295045892
• UDI-Public: 10603295045892
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 1516-20-706
• Device Catalogue Number: 151620706
• Device Lot Number: C72228
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FB INSRT SZ 7 6MM; ATTUNE CR FEM LT SZ 7 CEM; ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL DOME PAT 41MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE CR FB INSRT SZ 7 6MM; ATTUNE CR FEM LT SZ 7 CEM; ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL DOME PAT 41MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR