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

Catalog Number UNK HIP ACETABULAR LINER METAL

Device Problems Difficult to Remove (1528); 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); Distress (2329); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 03/07/2022

Event Type  Injury  

Event Description

Mom pinnacle litigation record received.Patient alleges heavy metal poisoning from the toxic heavy metal released, pain, injury to muscle and tissue, suffered additional scar tissue formation and will have replacements with decreased longevity, metallosis, ,metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, emotional trauma, and distress.Doi: (b)(6) 2008 - dor: (b)(6) 2022 (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.The device catalog number is unknown; therefore, udi is unavailable.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 the medical record, the patient was revised to address metallosis of the right hip, failed metal-on-metal hip replacement with a trochanteric fracture with bone loss from the metallosis in the acetabulum.Revision notes stated that the cup was anteverted approximately 60-70 degrees which made it nearly impossible to remove the metal liner.The acetabular component and head were revised.

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 (dob), a3, b5, b7 and h6 (clinical and device codes) h6 clinical symptoms code: metal related pathology (e1618) was used to capture blood heavy metal increased and metal poisoning.H6 clinical symptoms code: unspecified tissue injury (e2015) was 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).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), was not possible because the required lot code was not provided.

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 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.

Event Description

Medical records received.Medical records report dislocation (closed reduction).Metallosis of right hip status post failed metal on metal hip with trochanteric fracture with bone loss from the metallosis in the acetabulum as well as in the shelf of the greater trochanter.There was significant metallosis throughout the acetabulum all around the femoral neck within the acetabulum itself.Soft tissues were removed within metallosis fragments and then the cortical cancellous graft as well as cortical cadaver graft of all the ebony voids in the acetabulum.Osteolysis was also reported.

Event Description

Medical records were received: on (b)(6) 2022, the patient received a right hip revision to treat trochanteric fracture and metallosis from an mom construct.Upon entering metallosis and fracture were confirmed and significant acetabular bone loss identified.The metal liner was fused to the cup requiring revision of the cup and liner.The cup was revised with a multi-hole pinnacle requiring several screws.There is no indication the stem was revised after the orif was performed to treat the fracture.The head was revised with an assumed depuy ceramic head.The revised liner is assumed to be a depuy device.Doi: (b)(6) 2008 - dor: (b)(6) 2022 (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.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 #
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> (b)(4) investigation summary
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> it was reported that mom pinnacle litigation record received.Patient alleges heavy metal poisoning from the toxic heavy metal released, pain, injury to muscle and tissue, suffered additional scar tissue formation and will have replacements with decreased longevity, metallosis, ,metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, emotional trauma, and distress.Doi: (b)(6) 2008 - dor: (b)(6), 2022 (right hip) the product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4)_x-ray_images-received 28-sept-2023 the evidence provided indicates that the intervention angle does not observed an angle outside of specification according to the surgical technique, where the cup appears to be positioned at a 45 degree abduction angle.Additionally, no defects is noted in the antervension angle which should ideally fall within the range of 15 to 30 degrees, as specified in the surgical technique, page 18.It is recommended to adhere to the surgical technique.But with the evidence provided, it cannot be concluded that the liner cannot be disassemble from the head and the stem.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the unk hip acetabular liner metal 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
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15889164
• MDR Text Key: 304587876
• Report Number: 1818910-2022-24013
• 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: 11/30/2022

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?: No
• 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
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 03/01/2023; 03/09/2023; 09/01/2023; 10/12/2023; 03/19/2024
• Supplement Dates FDA Received: 03/08/2023; 03/09/2023; 09/04/2023; 10/16/2023; 03/21/2024
• 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 FEMORAL HEAD METAL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 104 KG