MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 6 CEM; KNEE FEMORAL

Model Number	1504-40-106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Synovitis (2094)
Date of Event	04/20/2021
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
Subject id: (b)(4).Study: dsj-2016-02 new.An adverse event has been generated.Please review this event as soon as possible.Event details event date: (b)(6) 2021.Alert date: (b)(4) 2021.Country of event: (b)(4).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: 29 jun 2018 event description (diagnosis): patch of synovitis lateral aspect of left knee patient details: patient identifier: (b)(4).Gender: male age (at time of consent): (b)(6).Height: (b)(6).Weight: (b)(6).Additional patient details: date of evaluation: (b)(6) 2021.Site awareness date: (b)(6) 2021.Event type: new event.If worsening event, please specify log line: blank did this event occur at the operative site ?: yes in the opinion of the investigator, was this adverse event expected/anticipated?: no is this a serious adverse event? if yes, select all that apply: no.Death: no.Life-threatening: no.Hospitalization (initial or prolonged): no disability or permanent damage: no congenital anomaly or birth defect: no required intervention to prevent permanent impairment or damage: no was the subject readmitted to hospital ?: no if yes, the date of readmission: blank the date of discharge: blank.Relatedness: is this event related to the study device?: definitely not is this event related to the study procedure ?: definitely not.Severity: mild.Outcome: ongoing a.Date of resolution or death: *complete additional adverse event form(s) as applicable: blank actions taken none: no arthroscopy: no closed reduction / manipulation: no irrigation & debridement: no open reduction internal fixation: no radiation: no injected medication: no aspiration/drainage: no oral medication: no physical therapy: no diagnostic intervention: yes surgery not related to the study knee: no revision of study joint: no if revision of study joint, please specify: a.Date of revision procedure: blank components removed attune femoral component: no attune femoral stem: no attune offset adaptor, femoral: no attune femoral sleeve: no attune femoral-distal augment: no attune femoral-posterior augment: no attune tibial insert: no attune tibial base: no attune tibial stem: no attune tibial sleeve: no attune offset adaptor, tibial: no attune tibial-medial augment: no attune tibial-lateral augment: no attune tibial-universal augment: no attune patellar component: no product details device log form log line: 1, (b)(4).Lot number id: h08204, device identifier: (b)(4).Device log form log line: 2, (b)(4).Stem catalog number: 151314060 lot number id: hn6846, device identifier: (b)(4).Device log form log line: 3, (b)(4).: femoral sleeve catalog number: 151101102, lot number id: hh7536 device identifier: (b)(4).Device log form log line: 4, (b)(4).: medial distal augment catalog number: 154706001, lot number id: hh8400, device identifier: (b)(4).Device log form log line: 5, (b)(4).Catalog number: 154706001, lot number id: (b)(4).Device identifier: (b)(4).Device log form log line: (b)(4).Catalog number: 150660006, lot number id: 8785491, device identifier: (b)(4).Device log form log line: 7, (b)(4).Catalog number: 151310060, lot number id: hm1963, device identifier: (b)(4).Device log form log line: 8 (b)(4).Catalog number: 151111102, lot number id: hj3191, device identifier: (b)(4).Device log form log line: (b)(4).: catalog number: 151710608, lot number id: 8715570, device identifier: (b)(4).Device log form log line: (b)(4).Cement catalog number: 3095040, lot number id: 8686274, device identifier: (b)(4).Updated by: (b)(6).Cf name chu alert01.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 CRS FEMORAL LT SZ 6 CEM
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork MA ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12786718
• Report Number: 1818910-2021-24749
• Device Sequence Number: 3992846
• Product Code: JWH
• UDI-Device Identifier: 10603295042198
• UDI-Public: 10603295042198
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 11/01/2021

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 Model Number: 1504-40-106
• Device Catalogue Number: 150440106
• Device Lot Number: H08204
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2016
• 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 6 CEM.; ATTUNE CRS RP INSRT SZ 6 8MM.; ATTUNE DIST FEM AUG SZ 6 4MM.; ATTUNE DIST FEM AUG SZ 6 4MM.; ATUN FEM SLV M/L 30MM HALF POR.; ATUN TIB SLV M/L 37MM HALF POR.; ATUNE PRESSFIT STR STEM10X60MM.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE REV RP TIB BASE SZ 6 CEM.; SMARTSET GHV GENTAMICIN 40G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 93 KG