MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 4 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device revealed evidence of polywear.No evidence of product malfunction or product error was indicated.The investigation did not establish that a broader investigation or corrective action was necessary.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.
Event or Problem Description
The patient's knee was revised due to knee pain, fall and loosening of the tibial component at the cement to implant interface.It was reported that during the patient's revision procedure, her primary attune cemented fixed bearing tibial tray was found to be loose.Upon further examination, surgeon noted that there was no bonding of cement on the underside of the tibial tray.The patient's primary tibial tray and fixed bearing posterior stabilized insert were removed and replaced by attune revision components.Surgeon said that the patient fell approximately one years after her primary procedure, injuring her operative knee, but did not make surgeon aware that she had fallen until a year later.At that time, x-rays were taken, which revealed that she had sustained a patella fractured when she fell.It had since healed.Surgeon believes the tibial tray may have become loose when the patient fell and injured her operative knee.He also believes that the design of the underside of the tibial tray may have been a contributing factor as well, since he has had to revise more than a half dozen primary attune cemented fb tibila trays that he had implanted due to loosening.A depuy smartset medium viscosity bone cement would have been used in the primary procedure, since the hospital only stocked smartset cement.The product codes and lot numbers for the cement are not available, since the cement used was hospital inventory ordered directly from depuy.No surgical delay.Doi: (b)(6) 2017, dor: (b)(6) 2021, left knee.

• Brand Name: ATTUNE PS FB INSRT SZ 4 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12508003
• Report Number: 1818910-2021-20669
• Device Sequence Number: 4986446
• Product Code: JWH
• UDI-Device Identifier: 10603295049791
• UDI-Public: 10603295049791
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1516-40-406
• Device Catalogue Number: 151640406
• Device Lot Number: H45286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR