MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 4 12MM; KNEE FEMORAL ACCESSORY

Model Number	1547-04-003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of attune revision due to pain at the distal tip of the stem in the tibia.Patient very unhappy and surgeon planned to revise the tibia component, but then needed to change the femoral component also.Patient has had multiple surgeries (b)(6) 2021 then again on (b)(6) 2021.This pc is the third revision.Doi: unknown.Dor (1st): (b)(6) 2021 (revision of competitor products).Dor (2nd): (b)(6) 2021.Dor (3rd): (b)(6) 2022.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.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.However, if the product is received at a later date, the investigation will be updated as applicable.
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 DIST FEM AUG SZ 4 12MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13869222
• Report Number: 1818910-2022-05234
• Device Sequence Number: 5263995
• Product Code: JWH
• UDI-Device Identifier: 10603295382737
• UDI-Public: 10603295382737
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/23/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1547-04-003
• Device Catalogue Number: 154704003
• Device Lot Number: J16D60
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 04/07/2022; 04/21/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/08/2022; 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• 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 RT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 8MM; ATTUNE DIST FEM AUG SZ 4 12MM; ATTUNE DIST FEM AUG SZ 4 12MM; ATTUNE POS FEM AUG SZ 4 8MM; ATTUNE POS FEM AUG SZ 4 8MM; ATUN PRESSFIT STR STEM14X110MM; ATUNE REV RP TIB BASE SZ 3 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female