MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ5 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-507
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); No Code Available (3191)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Patient received left primary attune tka to treat pain secondary to degenerative osteoarthritis.The patella was resurfaced, and competitor cement x 2 was utilized.Intraoperatively, the surgeon notes there was extensive degeneration of the lateral compartment and patellofemoral joint as well as grade ii and grade iii changes to the medial side.The natural femur and tibia were in valgus.There was extensive bone loss on the lateral facet of the natural patella.The procedure was completed without complications.Clinic note dated (b)(6) 2018 indicates the patient received a radiographic and physical exam of the left knee due to knee pain.The physical exam confirmed pain during passive rom.The radiographic study suggested loosening of the tibial tray.The surgeon recommended revision of the tray during office visit dated (b)(6) 2018.Patient received a left knee revision to treat persistent pain secondary to loosening of the tibial tray.Upon entering the joint, the surgeon discovered that the cement did not appear to be rigid and did not adhere to the bone nor the tibial tray.The cement to bone interface had a soft reactive fibrous tissue that was debrided.The tibial tray had subsided and was grossly loose and debonded at the cement to implant interface.The femoral component was well-fixed but revised.There was no reported product problem with the explanted tibial insert.The patella was well-fixed and retained.The patient received competitor revision products.The procedure was completed without complications.Doi: (b)(6) 2014.Dor: (b)(6) 2018.Left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

• Brand Name: ATTUNE CR FB INSRT SZ5 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10134567
• Report Number: 1818910-2020-13476
• Device Sequence Number: 3867171
• Product Code: JWH
• UDI-Device Identifier: 10603295045663
• UDI-Public: 10603295045663
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 11/30/2018
• Device Model Number: 1516-20-507
• Device Catalogue Number: 151620507
• Device Lot Number: 7803788
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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 FEM LT SZ 5 CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; ATTUNE CR FEM LT SZ 5 CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 104