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

Model Number 1365-51-100

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Ecchymosis (1818); Fatigue (1849); Foreign Body Reaction (1868); Headache (1880); Hearing Impairment (1881); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Synovitis (2094); Blurred Vision (2137); Dizziness (2194); Distress (2329); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Thrombosis/Thrombus (4440); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 11/16/2021

Event Type  Injury  

Event Description

Mom pinnacle litigation record received.Patient alleges elevated metal ion, suffered injury to his muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity, suffered injuries, pain, metallosis, metal wear, loss of enjoyment of life, limitation of daily activities, physical disability, experienced emotional trauma and distress, mental anguish, and economic loss, permanent instability and loss of balance, immobility, and suffering, doi: (b)(6) 2010, dor: (b)(6) 2021, (unknown hip).

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.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 a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update 3/15/2023.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.

Event Description

After a review of the medical records, the patient was revised to address hip pain, elevated metal ions, metallosis with synovitis.The operative note reported fluid with the joint and was slightly tinged gray.There was some dark gray charcoal appearing around the trunnion and femoral head.Affected side: 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.Clinical symptoms code: fatigue (e2312) used to capture weakness and fatigue.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 the medical records clinical visit reported lateral hip pain, elevated metal ions, discomfort, weakness, walking difficulties, fatigue, sleep disorder, dizziness, and limited adl.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays evidence were reviewed, and nothing indicative of a device nonconformance was observed, therefore the reported allegation was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

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).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: b7.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).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 Description

After review of the medical records received.Clinical visit (b)(6) 2015 reported hip pain, avascular necrosis of the left hip, headache, numbness.Blurred vision, hearing loss, kidney stones, joint pain, stiffness, weakness, rash, muscle pain, itching, lightheadedness, tingling , head injury, easy bruising , bleeding and enlarged veins.

• Brand Name: ASPHERE M SPEC 12/14 36 +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): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14874666
• MDR Text Key: 295066832
• Report Number: 1818910-2022-12062
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033929
• UDI-Public: 10603295033929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/30/2022

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: 03/31/2015
• Device Model Number: 1365-51-100
• Device Catalogue Number: 136551100
• Device Lot Number: 3089009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/04/2022; 03/15/2023; 05/20/2023; 06/02/2023; 08/21/2023; 11/01/2023; 11/07/2023
• Supplement Dates FDA Received: 07/04/2022; 03/17/2023; 05/31/2023; 06/05/2023; 09/15/2023; 11/06/2023; 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; ASPHERE M SPEC 12/14 36 +1.5; CORAIL2 NON COL HO SIZE 13; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX40MM; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM; UNK HIP ACETABULAR LINER METAL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White