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 Code	Naturally Worn (2988)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Type of Reportable Event	Malfunction
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, a follow-up medwatch will be filed as appropriate.
Additional 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 or Problem Description
Ppf and medical records received.Ppf alleges meta wear and metallosis.After review of medical records, there is no revision reported.Doi: (b)(4) 2008.Dor: none reported, right hip.Please see (b)(4) for left hip.

• 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: 9548215
• Report Number: 1818910-2020-00502
• Device Sequence Number: 2408059
• Product Code: JDI
• UDI-Device Identifier: 10603295033028
• UDI-Public: 10603295033028
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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 Model Number: 1365-08-000
• Device Catalogue Number: 136508000
• Device Lot Number: 2437563
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/28/2020
• 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