MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-506

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

Patient Problems Foreign Body Reaction (1868); Inflammation (1932)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Initial report: the patient was revised to address collapse medial tibial plateau and loosening of the tibia at the cement to implant interface, competitor cement was used.Tibial baseplate prosthesis was grossly loose and removed from patient's bone by hand; metallosis in the joint's soft-tissue was discovered.Bottom side of the baseplate appeared to be covered in fat with lipid wave infiltration.Doi: (b)(6) 2013; dor: (b)(6) 2018; right knee.Medical records were then received and reviewed and provided the following: on (b)(6) 2018, the patient underwent a right knee revision to address metallosis, tibial tray migration, and tibial loosening at the cement to implant interface.The surgeon noted minimal bone loss with removal of the tibial tray and well-fixed femoral component.A near complete synovectomy was completed due to inflamed tissue.The tibial tray, tibial insert, and femoral component were revised.The patellar component was retained.The patient was revised with depuy products and depuy cement x 3.There were no indicated intra-operative complications.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.Per internal procedures, the event information was reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Investigational inputs were requested as indicated per internal procedures for this failure mode.The received x-rays and explant photographs were reviewed as part of the investigation.All applicable x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified.No information received with this individual complaint indicated 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.Depuy considers the investigation closed at this time.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 PS FB INSRT SZ 5 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 12024804
• MDR Text Key: 262150119
• Report Number: 1818910-2021-12986
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295049937
• UDI-Public: 10603295049937
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 1516-40-506
• Device Catalogue Number: 151640506
• Device Lot Number: 298974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM.; ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE PS FEM RT SZ 5 CEM.; ZIMMER PALACOS BONE CEMENT.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female