MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 ARTICULEZE M HEAD 36MM -2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136550000

Device Problems Material Discolored (1170); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994); Visual Impairment (2138); Weakness (2145); Hypoesthesia (2352); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: unknown hip femoral head; unknown hip acetabular liner; unknown hip acetabular cup; unknown hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ consumer.

Event Description

Patient communication received.It was reported that the patient had a hip replacement in 2006.She was experiencing weakness and clicking in the hip.She was also feeling a little light headed off and on and the eyesight was getting worse for both near and farsightedness.Her cobalt level was 40.0 and the surgeon recommended for a hip revision.All mentioned issues are associated with high cobalt.

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.

Event Description

In addition to what previous alleged, claim letter alleged that during revision surgery, it was discovered that there was an issue at the trunion, this is the connection of 36 mm-2 cobalt chrome head to the corail stem, and there was also a significant dark material at the trunion.

Manufacturer Narrative

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

• Brand Name: ARTICULEZE M HEAD 36MM -2
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7893749
• MDR Text Key: 120860740
• Report Number: 1818910-2018-69888
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

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 Expiration Date: 04/30/2013
• Device Catalogue Number: 136550000
• Device Lot Number: 2617124
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 09/25/2018; 10/17/2018
• Supplement Dates FDA Received: 10/03/2018; 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2008
• 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): Other
• Patient Age: 72 YR