MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 5 14MM; KNEE TIBIAL INSERT

Catalog Number	151710514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Event date: blank alert date: 28-jun-2019 country of event: ous procedure: type of revision - operative details part 1: full procedure: knee revision using attune - operative details part 2: ps rp operative side: left date of surgery: (b)(6) 2019 event description (diagnosis): operative wound dehisced central 8cms: further revision surgery required updated event description: clinical adverse event received for operative wound dehisced central 8cms: wound dehiscence requiring dair.Event is serious and is considered severe.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2019 date of event: 26 jun 2019 (left knee) treatment: irrigation & debridement.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not perform.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 : 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 14MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19645800
• Report Number: 1818910-2024-14395
• Device Sequence Number: 12700438
• Product Code: NJL
• UDI-Device Identifier: 10603295055945
• UDI-Public: (01)10603295055945(10)8732857(17)230131
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 01/31/2023
• Device Catalogue Number: 151710514
• Device Lot Number: 8732857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2018
• 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 5 CEM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE POS FEM AUG SZ 5 8MM; ATUN FEM SLV M/L 45MM HALF POR; ATUN TIB SLV M/L 45MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 4 CEM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown