MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 4 CEM; KNEE FEMORAL

Model Number	1504-40-104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient had primary surgery in 2013 - implant stickers attached.In 2022, tibia loose and joint unstable and lax.Revision of both components today at (b)(6) hospital.Surgeon commented that ¿pitting was evident¿.Pre-op x-rays also attached.Doi: (b)(6) 2013.Dor: (b)(6) 2022.Unknown knee.
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.
Event or Problem Description
Additional information received states that no extension to surgical time was reported.No depuy cement is listed in the patient's primary usage.Assumed to be competitor cement and the affected side of the patient was the left knee.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.Through follow up it is now understood there is no allegation associated against a product malfunction.Review of the x-ray evidence found nothing indicative of a device nonconformance.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 (mre) was not performed.Corrected: g1.

• Brand Name: ATTUNE CRS FEMORAL LT SZ 4 CEM
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16060027
• Report Number: 1818910-2022-26156
• Device Sequence Number: 13955484
• Product Code: JWH
• UDI-Device Identifier: 10603295042174
• UDI-Public: 10603295042174
• 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: 2016
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 12/28/2022

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 Model Number: 1504-40-104
• Device Catalogue Number: 150440104
• Device Lot Number: 727933
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 01/31/2023; 02/20/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 02/03/2023; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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 CRS FEMORAL LT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 6MM; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 38MM; COMPETITOR CEMENT ( UNKNOWN MFG)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female