MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-006

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 07/28/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was revised to address pain, instability and loosening of the tibial tray at the cement to implant interface.Unknown cement was used.Full revision performed leaving patella implant in place.Doi: (b)(6) 2014.Dor: (b)(6) 2022.Affected side: left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary, no device associated with this report was received for examination.All available x-rays and photographs were reviewed, and there is not evidence that the implant loosening is product related.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 this medwatch report was initially submitted on 9/23/2022.This report is being resubmitted as this report failed submission as a result of the electronic gateway.Please reference fda ticket csh-28330 for additional details.

• Brand Name: ATTUNE FB TIB BASE SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15217089
• MDR Text Key: 297782784
• Report Number: 1818910-2022-15726
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042402
• UDI-Public: 10603295042402
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-00-006
• Device Catalogue Number: 150600006
• Device Lot Number: 7767170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2013
• 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 6 CEM.; ATTUNE PS FB INSRT SZ 7 6MM.; ATTUNE PS FEM LT SZ 7 CEM.; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN).; UNK ATTUNE KNEE PATELLA.
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 150 KG