MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CEMENTED STEM 14X80MM; KNEE STEMS

Model Number	1512-14-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	02/24/2021
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
Records state that the patient underwent a r primary total knee arthroplasty in 2019 using unknown implants.She then developed a postoperative infection requiring a 1-stage exchange in (b)(6) 2020 using "true components" of unknown manufacturer.The chronic infection continued and was cleared with antibiotics.She underwent a full revision on (b)(6) 2020 using depuy components.Physician check-up on (b)(6) 2020 states she sustained a fall and continued to have pain, fluid overload and reactive cellulitis in the right leg.On (b)(6) 2021 an mri showed nondisplaced fx of the right tibia adjacent to the stem.Patient was told to use a walking boot with weight restrictions.A search of the clinical database revealed no indication of the manufacturer of the unknown implants.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2021, (right knee).
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.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CEMENTED STEM 14X80MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11544095
• Report Number: 1818910-2021-05759
• Device Sequence Number: 14476012
• Product Code: JWH
• UDI-Device Identifier: 10603295475170
• UDI-Public: 10603295475170
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• 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: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 1512-14-080
• Device Catalogue Number: 151214080
• Device Lot Number: J61G02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/22/2021
• 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 3 CEM; ATTUNE CRS RP INSRT SZ 3 14MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 3 4MM; ATTUNE REVISION CEMENTED STEM 14X80MM; ATTUNE REVISION CEMENTED STEM 14X80MM; ATUN TIB AUG LM/RL SZ 3/4 10MM; ATUN TIB AUG RM/LL SZ 3/4 10MM; ATUNE REV RP TIB BASE SZ 3 CEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MEDIUM UNIVERSAL CEMENT RESTRICTOR; MEDIUM UNIVERSAL CEMENT RESTRICTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 86