MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICUL/EZE CER BALL 32 +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number	1365-77-000
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
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.Investigation summary: visual examination of the returned device finds nothing outward to suggest product error.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.
Event or Problem Description
Patient had implanted hip during 14 years, duraloc option pan (ceramic on ceramic).Pan began to squeak at the end of 2019.The head and liner were revised due to pain.Dor: (b)(6) 2020, right side.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
The patient was experiencing pain that led to the revision surgery.

• Brand Name: ARTICUL/EZE CER BALL 32 +5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; randall; warsaw IN 46581 0988
• MDR Report Key: 10421256
• Report Number: 1818910-2020-18303
• Device Sequence Number: 16891913
• Product Code: LZO
• UDI-Device Identifier: 10603295034346
• UDI-Public: 10603295034346
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K891083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2020

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: 1365-77-000
• Device Catalogue Number: K891083
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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: ARTICUL/EZE CER BALL 32 +5; DUR OPT CER INS 32/58,60; ARTICUL/EZE CER BALL 32 +5; DUR OPT CER INS 32/58,60
• Outcome Attributed to Adverse Event: Required Intervention