MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +12; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-54-000
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient "i had a hip replacement in 2014 that failed earlier this year.I am trying to find out if the parts that were used were recalled or should have not been used in combination.The part was depuy summit with a competitor titanium cup and cobalt chrome on polyethylene articulation." doi: 2014 : dor: none reported.Affected side: unknown.
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.
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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: b5, h6 (clinical code).H6 clinical code: code for blood heavy metal increased was updated to metal related pathology (e1618).
Event or Problem Description
Primary surgery occurred on 10/01/2014.Sticker sheets for primary implants are located within the sticker sheet attachment.The femoral side is depuy and the acetabular side is competitor.Revision operative notes (b)(6) 2020 indicated that the patient received a right total hip revision due to unspecified loosening, alval soft tissue reaction with chronic inflammation and necrotic tissue.And implant corrosion.It was noted that the femoral head was worn with corrosion between the head junction of the stem.The surgery was completed without indication of complication by the surgeon.

• Brand Name: ARTICULEZE M HEAD 36MM +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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14713453
• Report Number: 1818910-2022-11017
• Device Sequence Number: 13997242
• Product Code: JDI
• UDI-Device Identifier: 10603295033974
• UDI-Public: 10603295033974
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K980513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 05/31/2019
• Device Model Number: 1365-54-000
• Device Catalogue Number: 136554000
• Device Lot Number: 7926369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE M HEAD 36MM +12; COMPETITOR CUP (STRYKER); COMPETITOR LINER(STRYKER); SUMMIT POR TAPER SZ6 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female