MAUDE Adverse Event Report: DEPUY IRELAND ¿ REG. # 9616671 ATTUNE FB TIB BASE SZ 8 CEM; KNEE TIBIAL TRAY

Catalog Number 150600008

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A primary total knee procedure was performed using the attune implants.The surgeon used a cruciate retaining surgical technique and fixed bearing components.Final components were cemented into place and a 5 mm tibial insert was impacted.After waiting several minutes, the surgeon moved the knee through flexion and extension and noticed that the size 8 attune tibial baseplate was loose.The surgeon then removed the attune baseplate and cement.The surgeon decided to recut the tibia using im alignment and cut 2 mm more off the proximal tibia.The surgeon performed a trial reduction using a size 9 tibial baseplate and a 6 mm insert.The surgeon then mixed a new batch of smartset ghv cement and implanted a size 9 attune tibial baseplate and a 6 mm insert.

Manufacturer Narrative

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

• Brand Name: ATTUNE FB TIB BASE SZ 8 CEM
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND ¿ REG. # 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY IRELAND ¿ REG. # 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6412628
• MDR Text Key: 70185306
• Report Number: 1818910-2017-14846
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150600008
• Device Lot Number: 8380991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2016
• 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
• Patient Age: 62 YR