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

Model Number	1365-08-000
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Test Result (2695); No Code Available (3191)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to determine initial reporter contact information.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Medical records received.After review of medical records patient was revised due to pain, elevated cobalt and chromium level, failed left total hip arthroplasty with evidence of metallosis and corrosion at the head taper junction.Revision note reported a gray metal staining about the capsule.There was metal staining and corrosive changes in the trunnion of the stem.The cup was well fixed.Lab result for cobalt and chromium level are above 7 ppb.Mri does show pseudotumor about the left hip.Doi: (b)(6) 2010 (liner, head) doi: (b)(6) 2007 (stem) dor: (b)(6) 2019 left hip, second revision.
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.The device code corrosion is corrected to taper to capture the specific deficiency.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+12
• Common Device Name: 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: 10535904
• Report Number: 1818910-2020-20083
• Device Sequence Number: 2803021
• Product Code: JDI
• UDI-Device Identifier: 10603295033028
• UDI-Public: 10603295033028
• 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: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: 1365-08-000
• Device Catalogue Number: 136508000
• Device Lot Number: 2956056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12/14 ARTICUL 40MM M SPEC+12; PINNACLE MTL INS NEUT40IDX56OD; PRODIGY SM STAT LNG LT 13.5MM; 12/14 ARTICUL 40MM M SPEC+12; PINNACLE MTL INS NEUT40IDX56OD; PRODIGY SM STAT LNG LT 13.5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 85