MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 3 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); No Code Available (3191)
Date of Event	01/10/2020
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
The patient received a right total knee replacement due to end stage osteoarthritis.The patella was resurfaced, and competitor cement was utilized x2.The surgery was completed without indication of complication by the surgeon.The patient received a right total knee revision due to complex instability.Upon entering the joint, all implants were noted to be well fixed but revised., with the exception of the patella, which was debrided of surrounding scar tissue and left in place.Competitor implants and cement were utilized at revision.The surgery was completed without indication of complication by the surgeon.Doi: (b)(6) 2017; dor: (b)(6) 2020; right knee.
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.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, b7 and h6 (patient code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Clinic note dated 12 dec 2019: patient presents with persistent pain and instability.Physical exam confirms the instability.X-rays indicate possible loosening of the tibial tray.The physician notes the loosening of the tray was not confirmed.Patient is referred for revision surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : patient product x-ray images have been provided for review.No device associated with this report was received for examination.Provided images are jpeg files within patient medical records.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 PS FB INSRT SZ 3 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10235736
• Report Number: 1818910-2020-15040
• Device Sequence Number: 7082882
• Product Code: JWH
• UDI-Device Identifier: 10603295049647
• UDI-Public: 10603295049647
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/22/2020

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: 06/30/2018
• Device Model Number: 1516-40-305
• Device Catalogue Number: 151640305
• Device Lot Number: 404046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/07/2020; 08/20/2020; 02/09/2022
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 08/10/2020; 09/10/2020; 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FB INSRT SZ 3 5MM; ATTUNE PS FEM RT SZ 3 CEM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female