MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-00-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	10/29/2014
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
Medical records received 17 june 2019 and were reviewed 06 september 2019 for mdr reportability.On (b)(6) 2014, the patient underwent total left knee arthroplasty due to osteoarthritis.It was noted the patella was resurfaced.The surgeon reported no intraoperative complications and patient was transferred to recovery in stable condition.Attune knee components, and smartset cement x 2 were implanted in the procedure.On (b)(6) 2014, the patient underwent a left knee revision.There were no operative notes provided with the medical records.Doi: (b)(6) 2014 dor: (b)(6) 2014 (lt knee).
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 FEM LT SZ 5 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10778919
• Report Number: 1818910-2020-23856
• Device Sequence Number: 3773047
• Product Code: JWH
• UDI-Device Identifier: 10603295041146
• UDI-Public: 10603295041146
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 08/31/2023
• Device Model Number: 1504-00-125
• Device Catalogue Number: 150400125
• Device Lot Number: 7773985
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 04/14/2021
• 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 CR FB INSRT SZ5 7MM.; ATTUNE CR FEM LT SZ 5 NAR CEM.; ATTUNE FB TIB BASE SZ 4 CEM.; ATTUNE MEDIAL DOME PAT 35MM.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.; ATTUNE CR FB INSRT SZ5 7MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR