MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MB INSERT SZ4 9.5MM; PRSVN MB INSERT SZ4 9.5MM

Catalog Number 149815408

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Pain (1994); Tissue Damage (2104); Not Applicable (3189)

Event Date 04/30/2018

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

Knee revision for preservation uni knee joint replacement, grace hospital (b)(6) 2018.As per surgeon, the patient was experiencing pain.Revision of preservation tkjr completed.The tibial insert had split in half.The femoral component was loose.The patient had their primary surgery in 2005.There was metalosis present despite the tibial tray showing limited signs of wear.Jnj representative was present at the case.A primary pfc c ps rp tkjr was performed.Male patient aged 70 years.Unknown: jrn preservation tibial insert.Unknown: jrn preservation femoral component.

Manufacturer Narrative

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 devices confirms the reported event.Product problem has not been identified.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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: MB INSERT SZ4 9.5MM
• Type of Device: PRSVN MB INSERT SZ4 9.5MM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0998
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0998 ; 5743725905
• MDR Report Key: 7548779
• MDR Text Key: 109382045
• Report Number: 1818910-2018-60688
• Device Sequence Number: 1
• Product Code: MBD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 149815408
• Device Lot Number: 1117729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2003
• 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: 70 YR