MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-51-000

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

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Muscle/Tendon Damage (4532)

Event Date 02/22/2022

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

Revision completed due to suspected metallosis and large pseudotumor.Pinnacle metal liner and metal head were removed.Pinnacle poly liner and ts ceramic head were implanted.Doi: unknown.Dor: (b)(6) 2022.Affected side: right.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

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 : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: updated on 29 dec 2023.No device associated with this report was received for examination.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (dhr) reviews will not be performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

Event Description

Update ad 29 nov 2023.(b)(4).Medical records received.After review, the patient underwent revision of the right hip due to pain/aching discomfort in the hip and stiffness, massive pseudotumor formation with metal synovitis and necrotic tissue deep to the abductors, very large defect in the acetabular capsule and an inferiorly massive defect all the way down to the ischium.The posterior wall of the acetabulum showed significant deficits as did the anterior wall.A charnley retractor was placed.There was a massive palpable cyst deep to the rotators and it was under tension.In an effort to document the severity of her findings, video and photographs were taken as the capsule was opened with the rotators and this expressed high pressure, discolored, necrotic tissue and fluid that was stained dark brown to black from the metal and necrotic material.An abundant amount of tissue was removed as well as inflammatory debris, almost a full kidney basin worth by using curettes and even finger dissection to dissect all of the material away from the hip.This revealed the metal bearing in the articulation.The cup was slightly more vertical and slightly more retroverted than ideal, but certainly acceptable as her hip was reasonably stable even with the prior bearing in place including flexion at 90 degrees and internal rotation to about 70 degrees.A left hip arthroplasty have been mentioned, however, there were no untoward event reported.Implants used were depuy components made of ceramic and polyethylene ; zimmer/ biomet cup with dual mobility constrained liner.Doi: (b)(6) 2006.Dor: (b)(6) 2022.Affected side : right.

• Brand Name: ARTICULEZE M HEAD 36MM +1.5
• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13693378
• MDR Text Key: 286756765
• Report Number: 1818910-2022-04238
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033912
• UDI-Public: 10603295033912
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-51-000
• Device Catalogue Number: 136551000
• Device Lot Number: 1998779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PINNACLE MTL INS NEUT36IDX52OD.; UNK HIP BONE SCREW.; UNK HIP BONE SCREW.; UNK HIP FEMORAL STEM SUMMIT.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: White