MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS RP INSRT SZ 6 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-612
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 was revised to address pain and loosening of the tibial component at the cement to implant interface.Cement manufacturer was unknown.It was also reported that the tibia debonded from cement upon extraction with a moreland extractor and mallet.Femur was well fixed.Insert had visible wear on the posterior aspect both medially and laterally.Patella remains in situ.The surgeon will discuss intraoperative findings with the investigator.Doi: (b)(6) 2017; dor: (b)(6) 2019, right knee.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: the received device was forwarded to commercialized product development for evaluation.Review of the received device confirms the reported event.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Update: medical records received ad (b)(6) 2020 were reviewed on ad (b)(6) 2020 by a clinician to identify product issues and/or patient harms.Doi: (b)(6) 2017.Patient received an attune primary knee arthroplasty to treat advanced degenerative joint disease of the right knee.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Product information is provided on page 4.Dor: (b)(6) 2019.Patient received a right tka revision due to pain and loosening of the tibial component at the implant to cement interface.Intraoperative notes indicate a complete debonding of the tibial component from the cement and advanced wear of the tibial insert.The femoral component was well-fixed but revised.The patella was not revised.Depuy revision components were implanted with a competitor cone and cement restrictor as well as competitor cement.The procedure was completed without complications.Revision device product information is provided on pages 14-16.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: h6 (no code available (3191) is used to capture the device revision or replacement).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > the received device was forwarded to commercialized product development for evaluation.Review of the received device confirms the reported event.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Update 08-feb-2021: the investigation was re-opened upon receipt of additional information.The new information does not affect the existing investigation.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 RP INSRT SZ 6 12MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8726804
• Report Number: 1818910-2019-96608
• Device Sequence Number: 16596231
• Product Code: NJL
• UDI-Device Identifier: 10603295052616
• UDI-Public: 10603295052616
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/04/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1516-50-612
• Device Catalogue Number: 151650612
• Device Lot Number: 8529192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/23/2019; 02/14/2020; 02/08/2021
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/01/2019; 02/26/2020; 02/09/2021
• 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 MEDIAL ANAT PAT 32MM; ATTUNE PS FEM RT SZ 6 NAR CEM; ATTUNE RP TIB BASE SZ 5 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 65