MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE; METAL ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER METAL

Device Problem Naturally Worn (2988)

Patient Problems Ossification (1428); Fall (1848); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Distress (2329); 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 04/26/2021

Event Type  Injury  

Manufacturer Narrative

(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 complaint received ad 30 mar 2022.Patient was revised was due to heavy metal poisoning from toxic heavy metals.Also alleges pain, injury, pseudotumor formation, tissue destruction, metal wear, loss of enjoyment of life, limitation of daily activities, emotional trauma and distress.Doi: (b)(6) 2010, dor: (b)(6) 2021, unknown 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.

Event Description

Medical records received.On (b)(6) 2021, the patient was revised due to metallosis of the right hip arthroplasty with pseudotumor.Surgical indication reported patient developed metallosis related to metal-on-metal articulation with elevated cobalt and chromium levels and the mri revealed a large pseudotumor.Operative reported upon cleaning of trunnion of a black metallosis type tissue.The cup was removed but it was not grossly loose and the backside of the cup was intact.

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; the device associated with this report was not returned to depuy synthes for evaluation.Visual inspection of the provided series of patient radiographs did not find evidence that suggests the reported allegation was due to a product nonconformance.Based on the provided evidence, the investigation was not able to confirm the complaint.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 records evaluation (mre) was not performed as no lot number was provided for this device.

Event Description

Medical records received after review the following are pathologic findings: dual mobility: fluid collection, treated for bursitis, subjective complaints of " stiff but not painful ", associated signs and symptoms of pain and instability, there were calcification and shadow indicating synovitis in the imaging.A left hip arthroplasty happened on the same patient with ongoing left hip pain secondary to osteoarthritis, the patient's pain has persisted and progressed despite conservative treatments and therapies.Right hip: on (b)(6) 2018 patient reported having a "stiff but not painful" right hip.On (b)(6) 2019 the patient had a right greater trochanter bursa steroid injection to address chronic right hip pain.(b)(6) 2020: patient reported having right hip pain.The patient was treated for bursitis prior to the doctor¿s visit.Radiographs are reported to show calcification and shadow indicating synovitis.The patient also noted a leg length discrepancy.(b)(6) 2021 patient had pain in right hip, patient had fall with swelling.On (b)(6) 2023 pt consult: pain in right hip/thigh muscle wasting after metallosis from joint replacement.The patient has a history of right hip thw with revision and removal of pseudotumor.It was noted that the pseudo tumor returned after the removal a couple of years ago and was considered benign and not capsulated.The patient complains of weakness and frequent muscle cramps.Doi: (b)(6) 2010.Dor: (b)(6) 2021.Right hip.Left hip: the patient was also noted to have pain and stiffness in the left hip.The left hip without revision on records initially non-mom devices implanted was also coded for bursitis and synovitis.On (b)(6) 2016, the patient had a left total hip arthroplasty to address osteoarthritis.Depuy components were implanted.Doi: (b)(6) 2016.Doe: (b)(6) 2023.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.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).Investigation summary: according to the information received, ¿pinnacle litigation complaint received ad 30 mar 2022.Patient was revised was due to heavy metal poisoning from toxic heavy metals.Also alleges pain, injury, pseudotumor formation, tissue destruction, metal wear, loss of enjoyment of life, limitation of daily activities, emotional trauma and distress.Doi: (b)(6) 2010 / dor: (b)(6) 2021 / unknown hip¿.The product was not returned to depuy synthes, however photos were provided for review.(b)(4) medical records ad 20 may 2023, (b)(4) medical records ad 22 may 2023, (b)(4) _x-ray_images-received 07-nov-2023').All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.The overall complaint was not confirmed as the observed condition of the unk hip acetabular liner metal pinnacle would not contribute to the complained device issue.Based on the investigation findings and it has been determined that no corrective and/or preventative action is proposed.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: the device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK HIP ACETABULAR LINER METAL PINNACLE
• Type of Device: METAL ACETABULAR LINER
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14111367
• MDR Text Key: 289261148
• Report Number: 1818910-2022-06761
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL HEAD METAL; UNK HIP FEMORAL STEM CORAIL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 95 KG