MAUDE Adverse Event Report: DEPUY IRELAND 961610 ATTUNE PS FB INSRT SZ 6 5MM; KNEE TIBIAL BEARING/INSERT

Catalog Number 151640605

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 02/14/2017

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.(b)(4).Depuy synthes has been informed that the lot number is not available.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Patient was revised to address pain, osteolysis and tibial loosening.Loosening occurred at the cement/implant interface.Cement manufactured by depuy.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.(b)(4) has been undertaken to investigate attune post operative loosening further.The analyses and investigations eventually led to a new product development project, which will enhance fixation and make the product more robust to surgical technique per (b)(4).Corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).Initial reporter occupation: non-healthcare professional concomitant med products: attune fb tib base sz 4 cem; attune medial dome pat 38mm; smartset ghv gentamicin 40g two batches; unknown attune femur component.

Manufacturer Narrative

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

• Brand Name: ATTUNE PS FB INSRT SZ 6 5MM
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork IN ; EI
• MDR Report Key: 6344005
• MDR Text Key: 67801640
• Report Number: 1818910-2017-13002
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K090622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 151640605
• Device Lot Number: 533657
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: Not provided; 08/04/2018; 09/26/2018
• Supplement Dates FDA Received: 03/13/2017; 08/05/2018; 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 103