MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS RT SZ 6; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-11-206
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/16/2021
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
Patient was revised due to loosening of the tibial tray and femoral component at the bone to implant interface.Patient has a right total attune pressfit knee done by a surgeon.The tibial tray subsided and fallen into reverse slope.Surgeon went in with plans to revise the tibial tray only.Surgeon checked the femoral component and after multiple taps, it came off too.It is unknown if the femoral component would have grown in or not.It has been in for 8 weeks.The patella was well fixed and retained.When the revision components were implanted, the tibial tray sat 2mm proud.A thinner insert was utilized.Doi: (b)(6) 2021; dor: (b)(6) 2021; right knee.
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.

• Brand Name: ATTUNE FEM POR PS RT SZ 6
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12120562
• Report Number: 1818910-2021-14288
• Device Sequence Number: 17085745
• Product Code: MBH
• UDI-Device Identifier: 10603295042051
• UDI-Public: 10603295042051
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1504-11-206
• Device Catalogue Number: 150411206
• Device Lot Number: 9614311
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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 PS RP INSRT SZ 6 10MM.; ATTUNE RP TIB BASE SZ 5 POR.; ATUN TIB SLV M/L 37MM FULL POR.; ATUNE PRESSFIT STR STEM16X60MM.; ATUNE REV RP TIB BASE SZ 5 CEM.; ATTUNE PS RP INSRT SZ 6 10MM; ATTUNE RP TIB BASE SZ 5 POR; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 5 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR