MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-608
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/16/2014
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
Clinical adverse event received for inlay spin out.Event is not serious and is considered moderate.Event is definitely related to both device and procedure.Date of implantation: (b)(6) 2014.Date of event (onset): (b)(6) 2014.(left knee).Treatment: after manipulation under anesthesia - gypsum for 4 weeks.
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 and d11.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
In the event description of (b)(4), it was stated that "inlay spin out; (b)(6) 2014 - after an unhappy motion, 14 days after attune tka an inlay spin out happened.She came in 60 degree flexion.The wound, sensibility and vascularisation were without pathological findings.(b)(6) 2014 under anesthesia unbloody reposition could be provided.
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.

• Brand Name: ATTUNE CR RP INSRT SZ 6 8MM
• 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: 10456637
• Report Number: 1818910-2020-18854
• Device Sequence Number: 17137537
• Product Code: NJL
• UDI-Device Identifier: 10603295047896
• UDI-Public: 10603295047896
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1516-30-608
• Device Catalogue Number: 151630608
• Device Lot Number: 3547817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 10/23/2020; 02/07/2022
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 11/13/2020; 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2012
• 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 FEM LT SZ 6 CEM; ATTUNE RP TIB BASE SZ 6 CEM; REFOBACIN BONE CEMENT R 60X1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 82 KG