MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN PRESSFIT STR STEM12X110MM; KNEE STEMS

Model Number	1513-12-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/08/2020
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
Clinical adverse event received for trochanteric bursitis, hip and knee pain and crepitus.Event is not serious and is considered moderate.Event is possibly related to both device and procedure.Date of implantation: (b)(6) 2019, date of event (onset): (b)(6) 2020, (right knee).Treatment: injected medication (unspecified) and physical therapy.
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.A concomitant product was identified to be a competitor product used in conjunction with the previously reported adverse event.

• Brand Name: ATUN PRESSFIT STR STEM12X110MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12073124
• Report Number: 1818910-2021-13704
• Device Sequence Number: 14643845
• Product Code: JWH
• UDI-Device Identifier: 10603295043553
• UDI-Public: 10603295043553
• 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,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2021

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: 1513-12-110
• Device Catalogue Number: 151312110
• Device Lot Number: J13J72
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/25/2021; 08/12/2021
• Initial Report FDA Received Date: 06/27/2021
• Supplement Report FDA Received Date: 07/05/2021; 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CRS FEMORAL RT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 10MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE DIST FEM AUG SZ 5 8MM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE POS FEM AUG SZ 5 8MM; ATTUNE POS FEM AUG SZ 5 8MM; ATUN PRESSFIT STR STEM12X110MM; ATUN TIB SLV M/L 37MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; COMPETITOR BONE CEMENT (BIOMET)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 81