MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-224
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hearing Impairment (1881); Low Blood Pressure/ Hypotension (1914); Unspecified Mental, Emotional or Behavioural Problem (4430); Renal Impairment (4499)
Date of Event	12/02/2013
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Clinical adverse event received for acute renal failure, hypotension, altered mental.Status, deafness, and incidental stroke.Event is serious and is considered severe.Event is not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2013, date of event (onset): (b)(6) 2013, (right knee).Treatment: medical intervention/ modification; diagnostic intervention; observation.
Additional Manufacturer Narrative
Product complaint (b)(4) investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 PS FEM RT SZ 4 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11350919
• Report Number: 1818910-2021-03477
• Device Sequence Number: 16998298
• Product Code: JWH
• UDI-Device Identifier: 10603295041832
• UDI-Public: 10603295041832
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: 1504-10-224
• Device Catalogue Number: 150410224
• Device Lot Number: 372266
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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 MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ4 6MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET HV BONE CEMENT 40G; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ4 6MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 46