MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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	No Code Available (3191)
Date of Event	10/07/2020
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.
Event or Problem Description
It was reported the patient had to be revised again because the plastic liner disassociated from the bipolar shell.Patient had complained of a clicking noise and an x-ray showed the disassociation.Patient was revised to a unipolar construct.Doi: (b)(6) 2020, dor: (b)(6) 2020, affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the provided x-ray image finds what appears to be a separation of the poly liner component from the metal shell component.Photographs of the explanted devices have also been provided.It is not possible to determine the root cause using the provided images.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.Device history lot : lot 9543314 a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: ARTICULEZE M 28MM 1.5
• 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: 10726180
• Report Number: 1818910-2020-23166
• Device Sequence Number: 14474881
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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 Model Number: 1365-11-500
• Device Catalogue Number: 136511500
• Device Lot Number: 9543314
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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: SELF CENT HIP 42X28 RUST; SELF CENT HIP 42X28 RUST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 70