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

Model Number	1516-30-606
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2021
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 exchange of poly bearing.Attune bearing was upsized to a thicker poly due to a bearing spin out.Original primary op date was (b)(6) 2021.Doi: (b)(6) 2021, dor: (b)(6) 2021, unknown side.
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
1.Please confirm if the post on the insert came off from the tibial tray or did it just spin-out for more than 90 degrees? the insert spin out was more than 90 degrees.2.What was the posterior slope on tibia at the primary surgery? 5 degrees.3.Was the poly bearing used in the primary surgery too small? no it was the correct poly used at the time of the primary.4.Affected side? left.
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: product code 151630606, work order 9683009 was manufactured on (b)(6) 2021.18 parts were manufactured per specification and all raw materials met specification.There was no scrap associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.There were no non-conformances associated with this lot.

• Brand Name: ATTUNE CR RP INSRT SZ 6 6MM
• 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: 12569034
• Report Number: 1818910-2021-21804
• Device Sequence Number: 972647
• Product Code: NJL
• UDI-Device Identifier: 10603295047872
• UDI-Public: 10603295047872
• 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
• Report Date (Section B): 09/19/2021

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: 1516-30-606
• Device Catalogue Number: 151630606
• Device Lot Number: 9683009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/19/2021
• Supplement Date Received by Manufacturer: 10/01/2021; 12/20/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/12/2021; 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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 6MM.; ATTUNE CR RP INSRT SZ 6 6MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female