MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE PS FEM LT SZ 8 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-108

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)

Event Date 10/21/2017

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

18 may 2018 medical records received.After review of the medical records for mdr reportability, the patient was revised to address a metal allergy to the left total knee replacement.The surgeon reported that the patient "appeared to be allergic to some of the components of the depuy prosthesis¿ the patient also had pain and swelling.Doi: (b)(6) 2016; dor: (b)(6) 2017 (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

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:  corrected: h6 (device).

• Brand Name: ATTUNE PS FEM LT SZ 8 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7607249
• MDR Text Key: 111262483
• Report Number: 1818910-2018-62369
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041658
• UDI-Public: 10603295041658
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• 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: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-108
• Device Catalogue Number: 150410108
• Device Lot Number: 8295197
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR