MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-05-000

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Distress (2329); Discomfort (2330); Depression (2361); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/24/2021

Event Type  Injury  

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.

Event Description

It was reported that the surgeon requested poly liner for revision of pinnacle metal on metal liner and stem replacement in anticipation of loosening due to increase ion levels.Tissues appeared normal color and stem well fixed from point of view throughout procedure.No surgical delay.Doi: (b)(6) 2009; dor: (b)(6) 2021; unknown affected side.

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).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the injury (e20).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

A.Please indicate the affected side.The affected hip was on the left side.B.Can you please confirm if there was really a loosening of the stem? i cannot say definitively if there was loosening or not.The surgeon did work for a while to free the stem, but he did not state if it was loose.There appeared to be some proximal bone loss.I do not have any of the other items requested as the surgeon stated that the patient had contacted an attorney and wanted all information and explanted products.

Event Description

Additional information received states that the surgeon did work for a while to free the stem, but he did not state if it was loose.There appeared to be some proximal bone loss.The affected hip was on the left side.

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: 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 device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430 it has been determined that, for the mom platform and related allegations an mre is not required.

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: b1 (product problem), b5, g1, g2, h6 (clinical codes).H6 clinical code: appropriate term / code not available (e2402) is used to capture blood heavy metal increased.Unspecified tissue injury (e2015) is used to capture bone injury and soft tissue injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d3, e1, e2, e3, h6 (medical device problem code).E3 initial reporter occupation: lawyer.

Event Description

Patient alleges slow process of recovery from the surgery that would not have been necessary but for the defective nature of the pinnacle hip replacement, suffered injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.As a direct and proximate result of the defective pinnacle hip replacement, plaintiff suffered injuries, including but not limited to significant pain, tissue destruction, metal wear, metal poisoning, loss of enjoyment of life, emotional distress, physical disability and limitation of daily activities.

Event Description

Patient alleges slow process of recovery from the surgery that would not have been necessary but for the defective nature of the pinnacle hip replacement, suffered injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.As a direct and proximate result of the defective pinnacle hip replacement, plaintiff suffered injuries, including but not limited to significant pain, tissue destruction, metal wear, metal poisoning, loss of enjoyment of life, emotional distress, physical disability and limitation of daily activities.

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.E3 initial reporter occupation: lawyer.

Event Description

After review of medical records patient was revised on (b)(6) 2023, due to a failed left total hip arthroplasty with metal open metal bearing and metallosis.Surgical notes reported increasing hip pain with evidence of periprosthetic osteolysis.There was a fracture at the junction of the superior pubic ramus and anterior aspect of the acetabulum.Operative noted acetabular component was extracted and two screws remain solidly left in place.

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.

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 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 clinical code: metal related pathology (e1618) reported in the previous medwatch was used to capture blood heavy metal increased and metal poisoning.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 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 : 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.

Event Description

After a review of the medical records, the patient was revised to address metallosis with soft tissue reaction, hip pain, periprosthetic osteolysis, a large fluid collection and fracture of at the junction of the superior pubic ramus and anterior aspect of the acetabulum, local soft tissue reaction with osteolysis.Operative note reported that there was some evidence of deep tissue erosion in the anterior aspect of the gluteus medius, but the bulk of the hip abductor remained firmly attached to the trochanter and reactive synovial tissue was serially excised.Encountered brown fluid this was obtained was taken for culture and gram stain.There was a large amount of clay like brown material under the base of the trunnion similar to that encountered in the surrounding synovial tissues and this was removed.Clinical visit (b)(6) 2020 reported large left hip joint effusion, previous tear and atrophy of the gluteus minimus, chronic moderate tendinopathy of the proximal left common hamstring tendons without disruption, popping noise, stiffness, weakness, decrease rom, swelling, difficulty with mobility, activity limitation, discomfort and depression.There was some evulsion involving iliopsoas attachment, osteolysis in the acetabular component, 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.H10 additional narrative: added: a5, a6, b5, b6, b7 and h6 (clinical and device codes).H6 clinical symptoms code: swelling/edema (e2338) used to capture swelling and edema and unspecified tissue injury (e2015) used to capture soft tissue injury and bone injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+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 LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11638803
• MDR Text Key: 244608196
• Report Number: 1818910-2021-07488
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295032960
• UDI-Public: 10603295032960
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060031
• 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: 03/24/2021

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 Expiration Date: 07/31/2014
• Device Model Number: 1365-05-000
• Device Catalogue Number: 136505000
• Device Lot Number: 2961512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 04/07/2021; 04/07/2021; 05/04/2021; 03/14/2022; 03/18/2022; 03/01/2023; 04/15/2023; 05/15/2023; 05/22/2023; 06/28/2023; 10/03/2023
• Supplement Dates FDA Received: 04/21/2021; 04/25/2021; 05/05/2021; 03/18/2022; 03/22/2022; 03/07/2023; 04/21/2023; 05/15/2023; 06/01/2023; 06/28/2023; 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2009
• 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.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX40MM.; PINN SECTOR W/GRIPTION 56MM.; PINNACLE MTL INS NEUT40IDX56OD.; TRI-LOCK BPS SZ 3 HI OFFSET.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White