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

Model Number	1516-30-610
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(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
Revision and removal of a attune cementless rp size 6 tray and revision of poly to a cemented fixed bearing tray and fb insert.Revision was done due to another episode of bearing spin out.Patients primary operation was done by surgeon at sportsmed on the (b)(6) 2021.She had returned to alice springs (where she resides) and experienced a bearing spin out and returned to adelaide.Revision of attune poly and a increase in poly thickness occurred on the (b)(6) 2021 with the same surgeon at the same hospital.Physio was requested after the patient had been in a fixed splint for light movement and as the movement was applied by the physio, the bearing spun out again.Left side.
Event or Problem Description
1.Please clarify if there was surgical delay.No delay reported.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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.
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.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
Question: 1.What was the tibial slope at primary? did the surgeon ensure that the posterior slope was not too big (approx.3 degrees)? answer: "we used a primary cr cementless femur, we always set the slope to 5 degrees from the start.Unable to comment regarding additional slope being added, nothing was mentioned at the time about adding more slope.This patient was a bilateral case and we have no issues with the opposite side and the same instruments were used.".
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CR RP INSRT SZ 6 10MM
• 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: 12626888
• Report Number: 1818910-2021-22692
• Device Sequence Number: 19661503
• Product Code: NJL
• UDI-Device Identifier: 10603295047902
• UDI-Public: 10603295047902
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/30/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1516-30-610
• Device Catalogue Number: 151630610
• Device Lot Number: 9586637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 10/19/2021; 10/30/2021; 12/22/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 10/14/2021; 10/27/2021; 11/03/2021; 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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 CR RP INSRT SZ 6 10MM.; ATTUNE FEM POR CR LT SZ 6.; ATTUNE MEDIAL ANAT PAT 38MM.; ATTUNE RP TIB BASE SZ 6 POR.; ATTUNE CR RP INSRT SZ 6 10MM; ATTUNE RP TIB BASE SZ 6 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female