MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNKNOWN KNEE TIBIAL INSERT

Catalog Number UNK KNEE TIBIAL INSERT

Device Problem Insufficient Information (3190)

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

Event Date 05/17/2016

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

Reviewed medical records received on 14 may 2018.Left attune total knee revised to address pain and global knee instability.Revising surgeon debrided scar tissue medially and laterally from the knee joint, and exchanged the polyethylene insert for a thicker size.Also performed an it band release.Indicated that there was no evidence of implant loosening or malrotation/improper positioning of implants.No product/lot information available for primary implants or cement.Doi: (b)(6) 2014; dor: (b)(6) 2016; (left knee).

Manufacturer Narrative

Product complaint #
=
> pc-(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.

• Brand Name: UNKNOWN KNEE TIBIAL INSERT
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7583823
• MDR Text Key: 110532204
• Report Number: 1818910-2018-61699
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR