MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 44MM M SPEC+1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number	136561000
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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.(b)(4).
Event or Problem Description
Litigation papers allege after patient's surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium 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.It is also alleged as a result, patient has been experiencing severe pain and discomfort and inflammation in his left thigh and groin.It is further alleged patient also experiences a popping and snapping sensation in his hip-joint when walking or moving to and from a sitting position.It is also alleged patient will likely need to undergo revision surgery to replace the implant.Update ad 1 may 2018; the receipt of ppf and sticker sheets.Ppf has no allegations and no revision reported.The unknown depuy pinnacle hip that was reported in wpc was updated and added product code and lot number.Added dob of the patient and law firm in the facility name.
Additional 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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch will be filed as appropriate.

• Brand Name: 12/14 ARTICUL 44MM M SPEC+1.5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8013779
• Report Number: 1818910-2018-73716
• Device Sequence Number: 16502573
• Product Code: JDI
• UDI-Device Identifier: 10603295034032
• UDI-Public: 10603295034032
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2011
• Device Catalogue Number: 136561000
• Device Lot Number: 2272165
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention