MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD; METAL ACETABULAR LINER

Model Number 1218-87-456

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Arrhythmia (1721); Dyspnea (1816); Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Dizziness (2194); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Fibrosis (3167); 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 03/08/2021

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 mom litigation record received.Patient alleges heavy metal poisoning from the toxic heavy metals, suffered injury to his 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, muscle destruction, metal wear, metal poisoning, loss of enjoyment of life, and limitation of daily activities.Doi: (b)(6) 2008; dor: (b)(6) 2021; unk 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

After review of the medical records the patient was revised to address bearing surface wear prior to modular mom tha, hip pain, elevated metal ions and discomfort.Operative note reported yellow appearing synovial fluid, reactive synovitis, grayish metal staining of fibrous material and synovial tissues.Corrosive wear within the trunnion.Multi hole shell reported fibrous membrane but no evidence of grayish staining trunnionosis.There was some trunnion wear.Doi: (b)(6) 2008 dor: (b)(6) 2021 affected side: right hip.

Manufacturer Narrative

Product complaint #
=
> pc-(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
=
> 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.H10 additional narrative: added: a2 (age, dob), a3, b5, b6, b7, d4, h4, h6 (clinical codes) h6 clinical code: metal related pathology (e1618) is used to capture metal poisoning and blood heavy metal increased.Corrected: a1, d1, d2a, d10, g1.

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

In addition to what was previously reported in the medical records, a clinical visit reported fatigue and metallosis, reported during system review prior to revision are the following positive for palpitations, dyspnea with exertion, dizziness, lightheadedness and loss of balance, back pain, falls and joint pain.

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: fatigue (e2312) is being utilized to capture weakness.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.After review of the medical records the patient was revised to address hip pain and elevated metal ions.Operative note reported yellow appearing synovial fluid, reactive synovitis, grayish metal staining of fibrous material and synovial tissues, corrosive wear within the trunnion.Clinical visit on (b)(6) 2020 reported chronic hip pain, abnormal blood level of cobalt and metal wear, grinding and squeaking right hip, fatigue.Patient also experienced fogginess and difficult finding words, cognitive decline, antalgic gait, leg length discrepancy right hip is longer compared to the left, discomfort and occasional tingling in the shins and positive for weakness and numbness.

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 x-ray evidence found, nothing indicative of a device nonconformance.No signs of implant bearing wear were observed, 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: 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).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence found nothing indicative of a device nonconformance.No signs of implant bearing wear were observed on the provided evidence.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.According to the information received, ¿pinnacle mom litigation record received.Patient alleges heavy metal poisoning from the toxic heavy metals, suffered injury to his 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, muscle destruction, metal wear, metal poisoning, loss of enjoyment of life, and limitation of daily activities.Doi: (b)(6) 2008- dor: (b)(6) 2021 (unk hip)¿.The product was not returned to depuy synthes, however photos were provided for review.See "(b)(4) images ad 20 may 2023".Review of the x-ray evidence found nothing indicative of a device nonconformance.No signs of implant bearing wear were observed on the provided evidence.The overall complaint was unconfirmed as the observed condition of the pinnacle mtl ins neut40idx56od would not contribute to the complained device issue.Based on the investigation findings, 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 reported 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 (mre) will not be performed since mom systems are obsolete.

• Brand Name: PINNACLE MTL INS NEUT40IDX56OD
• Type of Device: METAL ACETABULAR LINER
• 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 IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13977035
• MDR Text Key: 288378325
• Report Number: 1818910-2022-05965
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• 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: 04/01/2022

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: 10/31/2013
• Device Model Number: 1218-87-456
• Device Catalogue Number: 121887456
• Device Lot Number: 2769647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/04/2022; 03/10/2023; 05/20/2023; 07/27/2023; 08/17/2023; 10/17/2023; 04/10/2024
• Supplement Dates FDA Received: 04/05/2022; 03/13/2023; 06/01/2023; 07/28/2023; 09/01/2023; 10/18/2023; 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2008
• 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: 12/14 ARTICUL 40MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MULTIHOLE II CUP 56MM; SUMMIT POR TAPER SZ5 STD OFF; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White