MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM TRI-LOCK

Catalog Number UNK HIP FEMORAL STEM TRI-LOCK

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

Patient Problems Ossification (1428); Abscess (1690); Anemia (1706); Endocarditis (1834); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330); Ambulation Difficulties (2544); Unspecified Mental, Emotional or Behavioural Problem (4430); Embolism/Embolus (4438); Renal Impairment (4499); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.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

Unf and pinnacle mom medical records received.After review of the medical records the patient was revised to address hip pain, septic shock, mrsa resistant left hip joint, increase crp, 6 weeks high grade mrsa bacteremia with septic prosthetic and splenic abscess secondary to septic emboli, developed endocarditis, dress, kidney failure, anemia, weakness, walking difficulty, metallosis, necrosis, inflammation and infected left hip.Irrigation and debridement on (b)(6) 2022 due to painful left hip.Operative note reported thick trochanteric bursa, big mass og scar, purulent fluid mixed with metallosis and synovitis.Clinical diagnosis is sepsis of the hip.Acute and chronic inflammation and necrosis.Second irrigation and debridement on (b)(6) 2022 due to infected left hip and hematogenously seated from endocarditis.Operative note reported turbid fluid left hip intracapsular and soft tissues, endocarditis with vegetation on the aorta were encountered, large amount of pus and metallosis tissue in the left hip area.There was an increased in crp and white blood cells.Doi: (b)(6) 2007.Doe: (b)(6) 2022 irrigation and debridement left hip.Doe: (b)(6) 2022 irrigation and debridement left hip.Dor:unrevised.

Event Description

Patient claim letter alleges pain, limited adl, delirium, elevated metal ion, metallosis, septic shock, necrosis, infection, mrsa, acute and chronic inflammation, increase crp, splenic abscess and septic emboli.The patient developed endocarditis, dress syndrome, kidneys failure, anemia, weight bearing, weakness and walking difficulty.Patient suffered six weeks hospitalization, 2 debridement surgeries, 6 weeks iv medication, endocarditis, renal failure and drug reaction with dress syndrome, kidney damage and thyroid and infection.After review of the medical records, clinic visit and operative note on irrigation and debridement reported pain, discomfort, limited range of motion, infection, developed endocarditis, renal failure and drug reaction with dress syndrome, kidney and thyroid damage.Fist i and d due to sepsis and with acute and chronic inflammation and necrosis.Second i and d is due to recurrent infection and encountered endocarditis.There is no indication of revision in this medical record since patient is hesitant due to possible more serious complication.However, revision is possible in the near future.Patient is seeking settlement for the damages and injuries experience.Doi: (b)(6) 2007 dor: unrevised left hip (mom).

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 : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

After review of the medical records, clinical visit reported pseudotumor formation, effusion and bursitis.There is moderate to severe narrowing of left ischio-femoral interval secondary to heterotopic ossification medial to the femur.Susceptibility artifacts arising from the metallic hardware limits visualization of surrounding structure in bilateral hip.Likely causing impingement of the quadratus femoris muscle.Mild tendinosis of left hamstring tendon these are from mri findings on (b)(6) 2021.There were no information pertaining to the right hip implants if depuy products were involved.

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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.

• Brand Name: UNK HIP FEMORAL STEM TRI-LOCK
• Type of Device: 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: 15475824
• MDR Text Key: 300582648
• Report Number: 1818910-2022-18556
• 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
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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 TRI-LOCK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2023
• 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: 36 MM METAL ON METAL FEMORAL HEAD MEASURING 1.6 +; 50 MM ACETABULAR PINNACLE CUP; METAL INSERT 36 MM X 50 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female