MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-53-000

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Synovitis (2094); Osteolysis (2377); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/30/2020

Event Type  Injury  

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 Description

Clinical notification received for revision of right total hip to address osteolysis date of implantation: (b)(6) 2010.Date of revision: (b)(6) 2020; (right hip).Treatment: revision of head and liner.

Event Description

On (b)(6) 2020, the patient underwent a right hip revision to address osteolysis, elevated metal levels (values not given), early pseudotumor, and limb asymmetry.The surgeon noted synovitis and reactive change in the soft tissue, as well as gray discoloration consistent with metal debris.The trunnion was cleaned with a scratch pad to clear all corrosion.Massive osteolysis was noted around the femur, however, the femur was very well intact and retained along with the cup.The head and liner were revised.There were no indicated intra-operative complications.

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.H10 additional narrative: added: b5 and h6 (patient,device).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the blood heavy metal increase.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # : pc-(b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the provided x-ray images finds nothing indicative of a product problem.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 : a complaint database search and/or device manufacturing (dhr) reviews will not be performed.Per (b)(4) it has been determined that should related reports be identified a dhr review is not required.

• Brand Name: ARTICULEZE M HEAD 36MM +8.5
• Type of Device: 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: 11516883
• MDR Text Key: 240679811
• Report Number: 1818910-2021-05462
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033950
• UDI-Public: 10603295033950
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2021

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
• Device Operator: Health Professional
• Device Model Number: 1365-53-000
• Device Catalogue Number: 136553000
• Device Lot Number: 3064953
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 03/22/2021; 04/13/2021
• Supplement Dates FDA Received: 04/05/2021; 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; CORAIL AMT COLLAR SIZE 15; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; CORAIL AMT COLLAR SIZE 15; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 84