MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL SROM; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL SRO

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Deformity/ Disfigurement (2360); Joint Dislocation (2374); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 06/21/2022

Event Type  Injury  

Event Description

Mom pinnacle litigation record received.Patient alleges elevated metal ion, pain, metallosis, metal; wear, loss of enjoyment of life and limitation of daily activities.As a direct and proximate result of the defective pinnacle hip, patient suffered injury to muscle and tissue, and suffered additional scar tissue formation, emotional trauma and distress, and physical disabilities.Doi: (b)(6) 2007.- dor: (b)(6) 2022.

Manufacturer Narrative

Product complaint # : (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records were received and stated the following: after a review of the medical records, the patient was revised to address hip pain, pseudotumor, dislocation, and loosening of the acetabular component.Operative note reported extensive fluid in the hip joint, pseudotumor, and osteolytic material around the hip joint.There was extensive bone loss and scar tissue.When pulling out the cup there was movement even with 1 screw in place.Doi: (b)(6) 2007 dor: (b)(6) 2022 left 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), was not possible because the required lot code was not provided.H10 additional narrative: added: a2 (dob, age), a3, b5, b7 corrected: a1, d1, d3, d4 (catalog), d10, h6 (clinical and medical device problem code).

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: 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 report left hip bone grafting, osteolysis, and pseudotumor.

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 ad 17 oct 2023 received.The patient complained of left hip felt a pop and had popped out of placed.There was also an issues in range of motion.Left x-ray revealed an anteriorinferior dislocation of the left femoral prosthetic component from the acetabular cup.Mrr note was added by clinician.Updated event description: on (b)(6) 2022 notes a physical exam, patient was admitted s/p debridement of pseudotumor capsule and revision left total hip arthroplasty on (b)(6) 2022.Patient was revised to address left metal on metal total hip arthroplasty with pseudotumor, pain, along with addition of loose acetabular component.Patient had dislocated prior and had a successful reduction in the emergency room.During the revision, the surgeon observed pseudotumor, extensive osteolytic material, and loose acetabular component.Acetabular cup/liner and femoral head were revised.There was extensive bone loss noted.The femoral component was noted to be well fix.Competitor cup, locking screw and liner were implanted along with depuy ceramic head during this procedure.Patient was noted to have developed post operative blood loss anemia, but was noted to be stable before discharge, with no allegation of invasive intervention.Patient was also noted to have baseline low blood pressure, which improved with fluids.

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: unspecified tissue injury (e2015) is being utilized to capture bone injury & soft tissue injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK HIP FEMORAL HEAD METAL SROM
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• 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: 16086721
• MDR Text Key: 306531513
• Report Number: 1818910-2023-00081
• Device Sequence Number: 1
• Product Code: JDI
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL SRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2023
• 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; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 57 KG