MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 4 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-408

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Synovitis (2094); No Code Available (3191); Joint Contracture (4528); Swelling/ Edema (4577)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Patient was revised to address loosening of the tibial component at cement to implant interface.Competitor cement was used.It was also reported that the tibia was found to be grossly loose, completely debonded from the cement mantle.Surgeon made the decision to remove the femur as well.Lesions were discovered behind the femoral component.Patient was revised to a tc3 sigma/mbt rev tibia construct.Mild pitting was observed on the attune poly insert.Doi: (b)(6) 2014; dor: (b)(6) 2019; right knee.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient received a right knee revision to treat pain and contracture with suspected loosening.Upon entering the joint, synovitis was debrided, and excessive effusion was evacuated.The femoral component had bone erosion on the condyles and revised.The tibial tray was loosened and debonded at the cement to implant interface and revised.There was no reported product problem with the revised tibial insert.Patella was retained.The patient was revised with a depuy revision construct utilizing competitor cement.The procedure was completed without complications.

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.H10 additional narrative: added: b5, b7, d4 (expiration) and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1 and h6 (patient).Replaced surgical intervention with device revision or replacement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.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.H10 additional narrative: e3 initial reporter occupation: lawyer.

• Brand Name: ATTUNE PS FB INSRT SZ 4 8MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 8455216
• MDR Text Key: 139963692
• Report Number: 1818910-2019-88567
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295049814
• UDI-Public: 10603295049814
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 1516-40-408
• Device Catalogue Number: 151640408
• Device Lot Number: 393278
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 4 8MM; ATTUNE PS FEM RT SZ 4 NAR CEM; STRYKER SIMPLEX BONE CEMENT
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR