MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-52-000

Device Problem Naturally Worn (2988)

Patient Problems Wound Dehiscence (1154); Ossification (1428); Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Scar Tissue (2060); Vertigo (2134); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Numbness (2415); Ambulation Difficulties (2544); Paresthesia (4421); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

Pinnacle litigation record received.Patient alleges pain, elevated metal ion, fatigue, tumor that caused by metallosis due to the initial implant of the metal-on-metal pinnacle device, hemarthrosis, numbness and discomfort, fluid accumulation, bleeding into the hip joint, and swelling.Patient developed a football-sized pseudotumor and related necrosis, caused by metallosis due to the initial implant of the metal-on-metal pinnacle device causing him emotional distress.Plaintiff sustained and continues to suffer damages, including, but not limited to suffering, severe and possibly permanent injuries, disability, disfigurement, economic damages (including medical and hospital expenses) monitoring, rehabilitative and pharmaceutical costs, and lost wages and loss of future earnings capacity, inability to walk without a cane, bone loss, parasthesia in right leg, mark distention in right hip, debris, kidney cancer, thyroid issues, bell's palsy, and vertigo.Doi: (b)(6) 2005 ; dor: (b)(6) 2020 ; (right hip).

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).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received indicate that on (b)(6) 2021: the patient has a consult regarding his right hip with persistent swelling that has occurred nearly a year after his revision.He has been aspirated several times with no signs of infection.Chromium and cobalt levels are normal.He has some numbness and pain radiating down the back of his leg.Mri shows a very large pseudotumor around the right hip that has recurred as well as the possible loosening of the right cup.X-ray review shows osteolysis around the stem proximally on the medial side.(b)(6) 2022: physical therapy note indicates the patient had a second pseudotumor removal from his hip on (b)(6) 2021.He has weakness and difficulty walking requiring physical therapy treatments.It is unknown if any implants were revised.(b)(6) 2022: patient cancels physical therapy visits due to excessive ¿popping sounds¿ in his hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: update: 05-april-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: 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.H6 clinical symptoms code: fatigue (e2312) was used to capture fatigue and weakness.

Event Description

After a review of the medical record, the patient experienced an antalgic gate with a limp, side-lying abduction shows abductor weakness and cannot abduct the right leg against resistance, 1cm short supine and 3mm shorts on right.Cobalt was elevated and has ostial lysis.There is greater trochanteric bursitis with dehiscence of the right hip abductors which are scarred to the right and fluid consistent with pseudotumor was also noted.

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: h6 (clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received: on (b)(6) 2022, x-ray findings right total hip prosthesis with acetabular cup and femoral stem.No significant change in irregularity and minimal heterotopic ossification involving the right greater trochanter.Surgical drain in place with small amount of pneumarthrosis and subcutaneous emphysema.No evidence of periprosthetic fracture.

Event Description

Medical records received.After review of the records there is no new information pertaining to right hip implant.However, on (b)(6), 2021 x-ray findings right hip arthroplasty , homogenous radiodensities surround the joint and greater trochanter suggestion fluid or chronic reactive change.Moderately wide crescent of metal bone interface intratrochanteric implants residual greater trochanter without definite motion of the more distal portion.Possible erosion, possible pre existing deformities, bony resorption reaction homogeneous subtle radiodensity suggestion fluid or chronic induration around the hip.Distal stem without definite evidence of motion or loosening.

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, h6 health effect - clinical code.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: according to the information received, "pinnacle litigation record received.Patient alleges pain, elevated metal ion, fatigue, tumor that caused by metallosis due to the initial implant of the metal-on-metal pinnacle device, hemarthrosis, numbness and discomfort, fluid accumulation, bleeding into the hip joint, and swelling.Patient developed a football-sized pseudotumor and related necrosis, caused by metallosis due to the initial implant of the metal-on-metal pinnacle device causing him emotional distress.Plaintiff sustained and continues to suffer damages, including, but not limited to suffering, severe and possibly permanent injuries, disability, disfigurement, economic damages (including medical and hospital expenses) monitoring, rehabilitative and pharmaceutical costs, and lost wages and loss of future earnings capacity, inability to walk without a cane, bone loss, parasthesia in right leg, mark distention in right hip, debris, kidney cancer, thyroid issues, bell's palsy, and vertigo.Doi: (b)(6) 2005 - dor: (b)(6) 2020 (right hip)." the product was not returned to depuy synthes, however photos were provided for review.See attachment ((b)(4) x-ray_images - received 18-jul-223).The x-ray investigation revealed that articuleze m head 36mm +5 had nothing indicative of a device nonconformance.The provided evidence represents a post-revision event.The overall complaint was unconfirmed as the observed condition of the articuleze m head 36mm +5 would not contribute to the reported issue.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 was performed for the finished device (136552000 /1990639) product and lot numbers, and no non-conformances were identified.

Event Description

Medical records received.On (b)(6) 2023 office visit - patient noticed a slight increase in discomfort and also an increase in fluid located at his lateral hip.Some sensitivity on the right hip surgical site.

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.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 +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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13306545
• MDR Text Key: 284110416
• Report Number: 1818910-2022-01219
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295033936
• UDI-Public: 10603295033936
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/19/2022

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: 10/31/2010
• Device Model Number: 1365-52-000
• Device Catalogue Number: 136552000
• Device Lot Number: 1990639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 01/20/2022; 03/14/2023; 04/05/2023; 04/03/2023; 05/25/2023; 06/20/2023; 07/12/2023; 09/25/2023; 12/12/2023; 01/31/2024
• Supplement Dates FDA Received: 01/23/2022; 03/17/2023; 04/11/2023; 04/24/2023; 06/07/2023; 06/22/2023; 07/20/2023; 09/26/2023; 12/19/2023; 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2005
• 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 100 ACET CUP 56MM; PINNACLE MTL INS NEUT36IDX56OD; SOL SYS 8/18.0 LRG ST; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White