MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICULEZE M 28MM 1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-11-500
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Voluntary report received under mw5097266.It was reported that patient suffered a subcapital fracture of her right hip.Bipolar hip placed on 2020.The bipolar hip assembly failed and was removed on 2020.It was replaced with another device.The second device failed and was replaced on 2020.Doi: (b)(6) 2020; dor: (b)(6) 2020; right hip.

• Brand Name: ARTICULEZE M 28MM 1.5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11026998
• Report Number: 1818910-2020-27133
• Device Sequence Number: 777921
• Product Code: JDI
• UDI-Device Identifier: 10603295033073
• UDI-Public: 10603295033073
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K843909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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: 05/31/2025
• Device Model Number: 1365-11-500
• Device Catalogue Number: 136511500
• Device Lot Number: 9543314
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/31/2021
• 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: SELF CENT HIP 42X28 RUST.; SELF CENT HIP 42X28 RUST
• Outcome Attributed to Adverse Event: Required Intervention