MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE RP TIB BASE SZ 8 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150610008

Device Problems Failure To Adhere Or Bond (1031); Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Discomfort (2330); Not Applicable (3189)

Event Date 05/22/2018

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.

Event Description

Der states that the patient was complaining of knee pain after his primary knee was implanted.Loosening of the tibial component at the cement to implant interface.Depuy cement was used.Surgeon decided to take the patient to surgery to check components for loosening.The femoral component was stable.Surgeon commented that the tibial component did not have any cement on the underside.The original tibial component had been implanted with two boxes of depuy ghv bone cement but unable to get lot # since the hospital buys their cement directly from depuy.Surgeon removed all the cement from tibia and implanted attune rev tray sleeve and stem and replaced with an appropriate size poly.Doi: (b)(6) 2017; dor: (b)(6) 2018; left knee.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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. added: (patient code and device code).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE RP TIB BASE SZ 8 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7606310
• MDR Text Key: 111215108
• Report Number: 1818910-2018-62352
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042624
• UDI-Public: 10603295042624
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150610008
• Device Lot Number: 8519065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR