MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150400209
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Hematoma (1884); Unspecified Infection (1930); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint : (b)(4).Initial reporter occupation: lawyer.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
Medical records received ad 17 june 2019.The patient underwent a right knee tibial insert exchange, irrigation and debridement, manipulation, and placement of antibitoic beads due to cellulitis, suspected post-operative wound infection, patella tendon rupture, fall, stiffness, decreased range of motion, effusion, and hematoma.The surgeon noted he did not repair the patella tendon tear due to the fact there is suspicion of infection and did not want to have foreign bodies that could perpetuate further infection.The surgeon obtained intra-operative cultures to determine presence of wound infection.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2018 dor: (b)(6) 2018 right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the device associated with this report was not 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FEM RT SZ 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9260724
• Report Number: 1818910-2019-113344
• Device Sequence Number: 3934793
• Product Code: JWH
• UDI-Device Identifier: 10603295041245
• UDI-Public: 10603295041245
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 150400209
• Device Lot Number: 8208359
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR