MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 6 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-610
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	02/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Patient received a left attune total knee to treat severe degenerative joint disease.The patella was resurfaced and depuy cement x 2 was utilized.There were no indicated intra-operative complications.Patient received a left knee tibial insert exchange.The patient was experiencing pain, decreased range of motion, arthrofibrosis, and adhesions.The surgeon noted lysis of extensive adhesions.There were no indicated intra-operative complications.Doi: (b)(6) 2015, dor: (b)(6) 2016 left knee tibial insert.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FB INSRT SZ 6 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11373717
• Report Number: 1818910-2021-03777
• Device Sequence Number: 934720
• Product Code: NJL
• UDI-Device Identifier: 10603295050100
• UDI-Public: 10603295050100
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• 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): 02/12/2021

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 Model Number: 1516-40-610
• Device Catalogue Number: 151640610
• Device Lot Number: 305689
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/25/2021
• 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 FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FB INSRT SZ 6 10MM; ATTUNE PS FEM LT SZ 6 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FB INSRT SZ 6 10MM; ATTUNE PS FEM LT SZ 6 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR