MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 5 6MM; KNEE TIBIAL INSERT

Model Number	1517-10-506
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	06/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The primary surgery was performed on an unknown date via tka with another company¿s implants.After the primary surgery, the end of 2019, the removal surgery was performed (the date was unknown) by removing all implants (the reason was unknown).Beginning of the 2020, the revision surgery was performed with another company¿s implants (the date was unknown), but the infection occurred, and the surgeon set cement mold.On (b)(6) 2020, the surgeon confirmed subsiding of the infection, and the second revision surgery was performed by implanting depuy¿s implants.It was reported that the dislocation of the tibial insert (p/n: 151710506) occurred on (b)(6) 2020.The emergency third revision surgery was planned on (b)(6) 2020 by replacing the tibial insert.The surgeon thought that the dislocation of the tibial insert was caused by the patient¿s the rheumatics, his muscle and tissue¿s atrophy and inserting thin tibial insert.The surgeon found the patient¿s atrophy in the second revision surgery on (b)(6) 2020.And, he thought that implanting thin tibial insert brought rapid loosening of the patient¿s muscle and tissue, and the dislocation of the tibial insert occurred after the third revision surgery.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.H10 additional narrative: added: h6 (patient codes).H6 patient code: no code available (3191) used to capture the joint instability and absence of treatment.

• Brand Name: ATTUNE CRS RP INSRT SZ 5 6MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10221240
• Report Number: 1818910-2020-14864
• Device Sequence Number: 2641404
• Product Code: NJL
• UDI-Device Identifier: 10603295055907
• UDI-Public: 10603295055907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 1517-10-506
• Device Catalogue Number: 151710506
• Device Lot Number: 9021999
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/27/2020
• 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 RP INSRT SZ 5 6MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR