MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136553000

Device Problems Material Disintegration (1177); Naturally Worn (2988)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695)

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: articuleze m head 36mm +8.5 hip femoral head.Pinnacle mtl ins neut36idx52od hip acetabular liner.Unknown hip acetabular cup.Summit por taper sz5 hi off hip femoral stem.Initial reporter occupation: non-healthcare professional ¿ attorney.

Event Description

New unity record created in order to update legacy complaint number (b)(4).Litigation papers allege the following: after the surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into patient's blood and tissue and bone surrounding the implant.As a result, patient has been experiencing severe pain and discomfort and inflammation in his left thigh and groin.He also experienced a popping and snapping sensation in his hip-joint when walking or moving to and from a sitting position.Patient will likely need to undergo revision surgery to replace the implant.Doi: (b)(6) 2004; dor: none reported; (left side).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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: ARTICULEZE M HEAD 36MM +8.5
• 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 INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8028377
• MDR Text Key: 125791104
• Report Number: 1818910-2018-74185
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033950
• UDI-Public: 10603295033950
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2018

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: 08/31/2009
• Device Catalogue Number: 136553000
• Device Lot Number: 1229261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2004
• 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