MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 7 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

Model Number	1506-40-007
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2021
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)(6).Study: (b)(6).Clinical adverse event received for tibial loosening.Event is serious and is considered severe.Event is possibly related to device and is possibly related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2021, (right knee).Treatment: revision of insert, and both tibial and femoral revision constructs.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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.H10 additional narrative:  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: bfarm dhr review.Product description: atune crs fb tib base sz 7 cem.Product code: 150640007.Lot number: 9263527.1) quantity manufactured: (b)(4).2) date of manufacture: 9/11/2019.3) any anomalies or deviations identified in dhr: no anomalies or deviations identified in dhr.4) expiry date: 7/31/2029.5) ifu reference: (b)(4).

• Brand Name: ATUNE CRS FB TIB BASE SZ 7 CEM
• Common Device Name: ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
• 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: 12646808
• Report Number: 1818910-2021-22861
• Device Sequence Number: 1713107
• Product Code: JWH
• UDI-Device Identifier: 10603295042815
• UDI-Public: 10603295042815
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 10/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1506-40-007
• Device Catalogue Number: 150640007
• Device Lot Number: 9263527
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 11/22/2021; 11/26/2021; 01/04/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/24/2021; 11/29/2021; 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2019
• 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: ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE DIST FEM AUG SZ 8 8MM; ATTUNE DIST FEM AUG SZ 8 8MM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE POS FEM AUG SZ 8 4MM; ATTUNE PS FB INSRT SZ 8 5MM; ATUN FEM SLV M/L 30MM HALF POR; ATUN TIB AUG RM/LL SZ 7/8 10MM; ATUNE CRS FB TIB BASE SZ 7 CEM; ATUNE PRESSFIT STR STEM18X60MM; COPAL G+C BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 87 KG