MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-035

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/08/2018

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

On 18 may 2018 medical records received.After review of the medical records for mdr reportability, the patient was revised due to infection with loosening of the tibial component at the implant to cement interface.Competitor cement was utilized in each of the previous surgeries.All components removed.Competitor product placed.Doi: unknown for tibia tray and femoral component (prior to (b)(6) 2017).Doi: patella (b)(6) 2017.Doi: insert (b)(6) 2018.Dor: (b)(6) 2018 for all.

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, a follow-up medwatch will be filed as appropriate. .

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.H10 additional narrative: added: g3.Corrected: h6 (device).

• Brand Name: ATTUNE MEDIAL DOME PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7601502
• MDR Text Key: 111065452
• Report Number: 1818910-2018-62224
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295056683
• UDI-Public: 10603295056683
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1518-20-035
• Device Catalogue Number: 151820035
• Device Lot Number: 8517197
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR