MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 3 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-203

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 06/28/2021

Event Type  Injury  

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 Description

Patient was revised due to pain.Surgeon thought it was from a loose tibia.Upon removal of the tibia it appeared to be well fixed.Surgeon just revised the tibial side to an attune revision rp baseplate with a sleeve and stem.Doi: unknown dor: (b)(6) 2021 right knee.

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 3 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12196279
• MDR Text Key: 262438304
• Report Number: 1818910-2021-15510
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041740
• UDI-Public: 10603295041740
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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
• Device Operator: Health Professional
• Device Model Number: 1504-10-203
• Device Catalogue Number: 150410203
• Device Lot Number: 8432219
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM RT SZ 3 CEM; ATTUNE PS RP INSRT SZ 3 8MM; ATTUNE RP TIB BASE SZ 3 CEM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); ATTUNE PS FEM RT SZ 3 CEM; ATTUNE PS RP INSRT SZ 3 8MM; ATTUNE RP TIB BASE SZ 3 CEM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR