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 Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/11/2022

Event Type  Injury  

Event Description

It was reported that the patient had a replacement of ultamet liner with constrained liner and a new head.The patient has elevated chromium and cobalt serum levels.The patient complained of painful hip.No falls, traumas, or comorbidities.The patient had a large pseudo tumor of the entire greater trochanter and surrounding muscles.The ultamet liner was visibly not set flush in the cup.The cup position was quite good on x-ray.The liner was visibly sticking out of the inferior portion of the cup giving it verticality.The liner was removed in usual fashion with not visible damage to cup or liner.The ultamet liner was replaced with constrained liner and a new head.The current doctor informed that the patient is currently involved in litigation with jnj.The x-rays are available from the current doctor through his office.Chromium level-10.5 cobalt level-8.2 the implants that were left implanted: 1217-22-054, z83ck1000 1570-11-100, zf7c11000 doi: (b)(6) 2006, doe: (b)(6) 2022, affected side: left hip.

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.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> 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
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> 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.) e3 initial reporter occupation: (b)(6).

Event Description

Patient alleges injury to muscle and tissue, suffered additional scar tissue formation, metallosis, metal wear, metal poisoning, loss of enjoyment of life, and limitation of daily activities.Plaintiff has sustained and will continue to sustain severe physical injuries, severe emotional distress, mental anguish, economic losses, permanent instability and loss of balance, suffering, and immobility.Doi: (b)(6) 2006 dor: (b)(6) 2022 (left hip).

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.H6: metal related pathology (e1618) is being utilized to capture blood heavy metal increased & metal poisoning.Unspecified tissue injury (e2015) is being utilized to capture soft tissue injury & bone injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of medical records, medical records reported on (b)(6) 2022, the patient was revised due to metallosis right total hip.Operative reported that the patient has developed worsening limp and x-rays have demonstrated osteolysis with severe trochanteric bone loss and mri showed pseudotumor formation.Operative reported some dark staining on the trunnion suggestive of some mild trunnionosis.

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 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 Description

Affected side: right hip.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence was not able to confirm the complaint since no signs of wear were identified on the provided evidence.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

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.

• 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
• 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: 13336811
• MDR Text Key: 285545287
• Report Number: 1818910-2022-01507
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033950
• UDI-Public: 10603295033950
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/24/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2010
• Device Model Number: 1365-53-000
• Device Catalogue Number: 136553000
• Device Lot Number: 1926287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 02/23/2022; 06/20/2022; 03/01/2023; 05/20/2023; 06/28/2023; 08/21/2023; 09/29/2023
• Supplement Dates FDA Received: 02/24/2022; 06/20/2022; 03/08/2023; 05/31/2023; 06/29/2023; 09/06/2023; 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2005
• 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: PINN CAN BONE SCREW 6.5MMX30MM.; PINNACLE MTL INS NEUT36IDX54OD.; PINNACLE SECTOR II CUP 54MM.; SUMMIT POR TAPER SZ4 HI OFF.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 74 KG