MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-004

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should 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.

Event Description

Doctor claimed the femoral and tibial components were loose.They were then extracted from the patient.Patient consequence? :unknown.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Event Description

On (b)(6) 2018, patient was then revised for ongoing pain.Both femoral and tibial components were noted to be loose-interface not provided.Although, per review of this complaint, product evaluation confirmed loosening at implant/cement interfaces.Adhesions were noted intra-operatively as well.

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

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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

Medical records received were reviewed by a clinician to identify product issues and/or patient harms.Intraoperative fluoroscope imaging dated (b)(6) 2018 confirms placement of the left knee prosthesis.Blood and urine pathology reports dated (b)(6) 2018 confirm no infection present.

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.  corrected: h6 (no code available (3191) is used to capture the device revision or replacement).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATTUNE FB TIB BASE SZ 4 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: 7573583
• MDR Text Key: 110223767
• Report Number: 1818910-2018-61490
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/13/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-00-004
• Device Catalogue Number: 150600004
• Device Lot Number: 8226994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 09/13/2019; 09/13/2019; 03/25/2020; 08/18/2020
• Supplement Dates FDA Received: 10/11/2019; 10/11/2019; 04/06/2020; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM LT SZ 5 NAR CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR