MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Seroma (2069); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 09/08/2021

Event Type  Injury  

Event Description

Litigation records alleges heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury and requiring surgery to remove the defective hip replacements.Patient was consequently revised due to injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.Additionally, patient suffered pain , injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, incurred additional medical expenses, lost earning potential/ income, and ultimately emotional trauma and distress in the future.Doi: (b)(6) 2007, dor: (b)(6) 2021, affected side: unk.

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.Occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After a review of medical records, operative notes reported a large amount of fluid and blood, black-tinged stained tissue.There was a notable effusion and seroma evacuated through the peripheral area of the cup indicating a large defect on the posterior aspect and medial aspect of the cup.The cup was extracted and there was a severe bone loss.The affected side is the right 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: a2 (age, dob), a3, b5, b6, d10 and h6 clinical symptoms code: metal related pathology (e1618) used to capture metal poisoning and blood heavy metal increased 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.

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).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 : litigation records alleges heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury and requiring surgery to remove the defective hip replacements.Patient was consequently revised due to injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.Additionally, patient suffered pain , injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, incurred additional medical expenses, lost earning potential/ income, and ultimately emotional trauma and distress in the future.Doi: (b)(6) 2007, dor: (b)(6) 2021, affected side: unk.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).Visual inspection of the provided patient x-rays revealed there were no product problems observed with unk hip femoral stem.Based on the provided photo, there was no evidence that suggests the reported adverse vent was due to a product non-conformance.The investigation was not bale to confirm the reported event.The overall complaint was unconfirmed as the observed condition of the unk hip femoral stem 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 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), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16635554
• MDR Text Key: 312219698
• Report Number: 1818910-2023-06827
• Device Sequence Number: 1
• Product Code: LPH
• 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: 03/29/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 07/14/2023; 08/21/2023; 10/11/2023; 11/13/2023; 12/07/2023
• Supplement Dates FDA Received: 07/24/2023; 08/30/2023; 10/13/2023; 11/14/2023; 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP METAL; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White