MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 4 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	11/22/2021
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
Patient underwent primary left attune tkr on (b)(6) 2018.Patient subsequently fell on (b)(6) 2018 and suffered a left distal femoral periprosthetic fracture.This was treated with distal femoral plating.Patient had swelling, fevers, erythema and pain on (b)(6) 2018, which was treated with antibiotics and settled.Now presenting back to surgeon with a 6 week history of pain, swelling, hyperextension and cellulitis left knee.Procedure today, arthrotomy and exploration left total knee replacement.Surgeon explored the prosthesis bone interface and was satisfied that the femoral and tibial components appeared well fixed still and not loose.He examined the distal femoral plates and removed one screw which was protruding.He stated the construct was still well fixed.He removed the existing 6mm poly and performed a trial with an 8mm poly.He was satisfied with the knee stability and rom.Proceeded to insert an 8mm poly and resurface the patients patella.Infection suspected, multiple specimens sent, but not confirmed.Doi: (b)(6) 2018, dor: (b)(6) 2021, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays and photographs were reviewed, and no evidence of anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CR RP INSRT SZ 4 6MM
• 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: 12959899
• Report Number: 1818910-2021-27457
• Device Sequence Number: 12114888
• Product Code: NJL
• UDI-Device Identifier: 10603295047636
• UDI-Public: 10603295047636
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1516-30-406
• Device Catalogue Number: 151630406
• Device Lot Number: 8606071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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 4 CEM; ATTUNE CR RP INSRT SZ 4 6MM; ATTUNE RP TIB BASE SZ 4 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female