MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 5 12MM; KNEE TIBIAL INSERT

Model Number	1517-10-512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Edema (1820); Inflammation (1932); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Date of Event	02/24/2020
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
The patient was revised to address shin pain caused by stem penetrating cortex.Claim record alleges persistent pain, discomfort, instability, difficulty ambulating and aseptic loosening of the tibial component at an unknown interface.Unknown cement was used.Radiographs and bone scan showed aseptic loosening and lysis around the tibial component.Doi: (b)(6) 2018.Dor: (b)(6) 2020.Right knee.
Event or Problem Description
On (b)(6) 2012, the patient received a right primary competitor knee to treat pain and effusion secondary to advanced degenerative joint disease.The patella was resurfaced, and competitor cement was utilized.The procedure was completed without complications.Doi: (b)(6) 2018: patient received a right revision attune tka to treat pain and selling secondary to loosening of a competitor knee system.Upon entering the joint, the surgeon identified and evacuated a synovial cyst and scar tissue.The competitor femoral component was well-fixed but revised.The competitor tibial tray was loosened at the cement to implant and cement to bone interface, the cement mantle along the tibial bone had a trampoline effect and there was a cyst in the anterior tibia.The competitor patella was well-fixed and retained.There was no reported product problem with the explanted competitor tibial insert.The procedure was completed without complications.Dor: (b)(6) 2020: patient received a right knee revision to treat pain secondary to tibial component loosening and collapse.Upon entering the joint, the surgeon identified and removed marked effusion and periarticular scar tissue.The femoral component was well-fixed and retained.The tibial tray, augment, sleeve, and stem had subsided medially and was loose at an unknown interface.There was a large soft tissue surrounding the tibial cement mantle that was removed.The surgeon notes there was minimal ingrowth on the tibial sleeve and the stem was pressing against the tibial cortex.The competitor patella was retained.There was no reported product problem with the explanted tibial insert.
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.
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.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 CRS RP INSRT SZ 5 12MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10065849
• Report Number: 1818910-2020-12205
• Device Sequence Number: 17067968
• Product Code: NJL
• UDI-Device Identifier: 10603295055938
• UDI-Public: 10603295055938
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2020

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: 10/31/2022
• Device Model Number: 1517-10-512
• Device Catalogue Number: 151710512
• Device Lot Number: 8655287
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 05/29/2020; 07/27/2021
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 06/10/2020; 07/28/2021
• 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 CRS FEMORAL RT SZ 5 CEM; ATTUNE DIST FEM AUG SZ 5 4MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN TIB SLV M/L 29MM HALF POR; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 4 CEM; ATUNE REV RP TIB BASE SZ 4 CEM; COMPETITOR BONE CEMENT; COMPETITOR KNEE PATELLA; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 4 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR