MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-06-000

Device Problem Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Osteolysis (2377); No Code Available (3191)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that there was revision of pinnacle metal on metal cup.The head and liner were removed and replaced with 40mm 1.5 delta ts head and 40mm + 410 liner.Explanted implants were sent to pathology.Doi: 2011; dor: (b)(6) 2019; unknown affected side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10026880
• MDR Text Key: 189975496
• Report Number: 1818910-2020-11721
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295032984
• UDI-Public: 10603295032984
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

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: 1365-06-000
• Device Catalogue Number: 136506000
• Device Lot Number: 3220587
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 120