MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 9 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-10-009
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/11/2016
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 ad (b)(6) 2021 were reviewed.On (b)(6) 2014, the patient had a left total knee replacement to address degenerative joint disease.Depuy components including depuy patella and depuy cement x2 was utilized during this procedure.On (b)(6) 2016, the patient had an explant left total knee to address pain and infection.The preoperative summary included that the tibia tray is in some varus and was ¿obviously loose¿, no interface provided.The femoral component was not loose, but was revised.No mention of revising the patella.There was no mention of the manufacturer of the spacers implanted during this procedure.Doi: (b)(6) 2014 dor: (b)(6) 2016 (left knee).
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE RP TIB BASE SZ 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11447812
• Report Number: 1818910-2021-04788
• Device Sequence Number: 11785164
• Product Code: NJL
• UDI-Device Identifier: 10603295042631
• UDI-Public: 10603295042631
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• 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): 02/26/2021

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 Expiration Date: 05/31/2024
• Device Model Number: 1506-10-009
• Device Catalogue Number: 150610009
• Device Lot Number: 7909573
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/07/2021
• 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 DOME PAT 41MM.; ATTUNE PS FEM LT SZ 8 CEM.; ATTUNE PS RP INSRT SZ 8 7MM.; ATTUNE RP TIB BASE SZ 9 CEM.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR