MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ8 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650806
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).D4-expiration date of the device was not provided.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Clinical adverse event received for slight gait instability left knee.Event is not serious and is considered mild.Event is possibly related to device.Event is not related to procedure.Date of implant: (b)(6) 2019.Date of event: unknown in 2023.(left knee).Treatment: recommendation for knee control in the orthopedic department.Depuy products used (no revision completed):.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.Product description: attune ps rp insrt sz8 6mm.Product code:151650806.Lot number: 8595683.1) quantity manufactured:(b)(4).2) date of manufacture: 10-aug-2017.3) any anomalies or deviations identified in dhr: no non-conformances / manufacturing irregularities related to the malfunction were identified.4) expiry date: 31-july-2022 5) ifu reference: 090200829.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : product description: attune ps rp insrt sz8 6mm product code:151650806.Lot number: 8595683.1) quantity manufactured:(b)(4).2) date of manufacture: 10-aug-2017.3) any anomalies or deviations identified in dhr: no non-conformances / manufacturing irregularities related to the malfunction were identified.4) expiry date: 31-july-2022.5) ifu reference: 090200829.

• Brand Name: ATTUNE PS RP INSRT SZ8 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17773518
• Report Number: 1818910-2023-19056
• Device Sequence Number: 7491414
• Product Code: NJL
• UDI-Device Identifier: 10603295052852
• UDI-Public: 10603295052852
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2023

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 Catalogue Number: 151650806
• Device Lot Number: 8595683
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 10/30/2023; 10/31/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/30/2023; 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• 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 MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 8 CEM; ATUN TIB SLV M/L 45MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 7 CEM; COMPETITOR PRODUCT (BIOMET CEMENT)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 130 KG