MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICUL/EZE BALL 32 +9 BL; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-23-000

Device Problem Corroded (1131)

Patient Problems Host-Tissue Reaction (1297); Cardiac Arrest (1762); Pain (1994); Loss of Range of Motion (2032); Renal Failure (2041); Tissue Damage (2104); Test Result (2695); No Code Available (3191)

Event Date 12/21/2011

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant medical products: articul/eze ball 32 +9 bl hip femoral head.Pinn mar +4 10d 32idx62od hip acetabular liner.Pinnacle sector ii cup 62mm hip acetabular cup.Aml high offset lg stat 15.0mm hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ patient (maude report).(b)(4).

Event Description

Maude report received stating that patient had developed limited movement issues and pain.The parts were cobalt and chromium.He had kidney failure, heart attack, numerous tumors near his hip replacement and cobalt and chromium poisoning.Doi: 2006; dor: n/a; unknown hip.

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: ARTICUL/EZE BALL 32 +9 BL
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8075111
• MDR Text Key: 127282835
• Report Number: 1818910-2018-75662
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033196
• UDI-Public: 10603295033196
• Combination Product (y/n): N
• PMA/PMN Number: K843909
• 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: 10/17/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 1365-23-000
• Device Catalogue Number: 136523000
• Device Lot Number: 2236798
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 02/11/2019; 05/11/2021
• Supplement Dates FDA Received: 02/18/2019; 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other