MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 7 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-10-007
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Revision completed due to pain/stiffness and loosening of the femoral component.Scar tissue was removed.All components were removed.Attune revision was implanted.The patella was removed so we could gain better access to the joint space.This was well fixed.The femoral component was very loose and 'fell off' when we were trying to remove the insert.Cement was well fixed at the implant/cement interface, but not at the cement/bone interface.The tibia was well fixed.The bone/cement interface was well fixed compared to the cement/implant interface.The surgeon said the primary surgery was done in 2017 where the patient had a bilateral knee replacement.As the patient notes weren't complete i had to do my best to read the lot numbers of the explanted components.The left side was revised (i think) on (b)(6) 2021 for pain and stiffness.I'm unsure about loosening.I don't know the pc number for this revision.
Event or Problem Description
Additional information received indicated that the surgeon attributed the stiffness and pain due to femoral loosening and scar tissue.Reason for revision was due to femoral component loosening.The surgeon noted this as the femoral component ¿fell off¿ with the majority of the cement fixed to the implant.With the tibia, he did say it was well fixed, but that it did come off with no cement fixed to the implant.He then mentioned that this looks like one of our ¿old tibial implants¿, before s+.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: 1.Was the loosening interface of the femoral component bone to cement? yes the cement was loose at the bone-cement interface.2.Was the loosening interface of the tibia tray cement to implant? i found the joint registry form and the reason for revision was due to loose femoral component.The tibial component was not loose, however there wasn¿t any cement bonded to the tray.

• Brand Name: ATTUNE RP TIB BASE SZ 7 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15697575
• Report Number: 1818910-2022-21558
• Device Sequence Number: 17842915
• Product Code: NJL
• UDI-Device Identifier: 10603295042617
• UDI-Public: 10603295042617
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2022

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: 1506-10-007
• Device Catalogue Number: 150610007
• Device Lot Number: 8551254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 11/18/2022
• Initial Report FDA Received Date: 10/30/2022
• Supplement Report FDA Received Date: 11/10/2022; 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FEM RT SZ 7 CEM; ATTUNE PS RP INSRT SZ7 6MM; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male