MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL

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

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Distress (2329); Discomfort (2330); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/23/2020

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 litigation complaint received ad 5 apr 2022.Patient was revised was due to metallosis, pseudotumor formation and suffered metal poisoning from the toxic heavy metals.Also alleges pain, injury, tissue destruction, metal wear, loss of enjoyment of life, limitation of daily activities, emotional trauma and distress.Doi: (b)(6) 2007, dor: (b)(6) 2020, 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.

Manufacturer Narrative

Product complaint # (b)(6).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, h6 health effect - clinical code.H6: metal related pathology (e1618) is being utilized to capture blood heavy metal increased & metal poisoning.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1.

Event Description

Medical records received.On (b)(6) 2020, the patient was revised due to failed meta on metal left total hip arthroplasty with metallosis and pseudotumor.Surgical indicated that the patient had pain swelling and evidence of significant elevated cobalt chrome ion levels and pseudotumor.The patient had and the liner was replaced with a poly liner and ceramic head.

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: b5 and h6 (clinical code) 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 were reviewed and pathologic findings from tissue samples: necrosis/necrotic.

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: swelling/ edema (e2338) is being utilized to capture swelling & edema.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 medical records, the patient was revised due to elevated metal levels, as well as severe pain and discomfort, moreover, difficulties standing, sitting, walking, climbing stairs, and performing normal daily living activities.The patient suffered from the inability to sleep due to his pain and discomfort.The surgeon noted that extensive clear serous fluid was encountered as well as metallosis and debris within his trochanteric bursa and capsule.And due to these observations, the surgeon performed extensive debridement of the tissue.Affected side: left.

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 was not able to confirm the complaint since no photos of the explanted device were received in order to observe this condition.No signs that could contribute to an audible sound were observed.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 records evaluation (mre) was not performed as no lot number was not available for this device.H10 additional narrative: added: b6, b7.

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.

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: b5 and h6 (clinical and device codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After a review of the medical records received, the patient was revised due to elevated metal levels, as well as severe pain and discomfort, moreover, difficulties standing, sitting, walking, climbing stairs, and performing normal daily living activities.The patient suffered from the inability to sleep due to his pain and discomfort.The surgeon noted that extensive clear serous fluid was encountered as well as metallosis and debris within his trochanteric bursa and capsule.And due to these observations, the surgeon performed extensive debridement of the tissue.On 02/08/2007, the patient had a non-cemented left total hip arthroplasty, to address degenerative joint disease.Depuy pinnacle was implanted during the procedure.Surgery page 849 of 1448.10/01/2020 lab values cobalt 27.5 ug/l, chromium 17.7 ug/l.(b)(6) 2020 mri of left hip notes predominantly fatty intra-articular mass, synovitis, large periarticular fluid collection, severe atrophy of the obturator internus and externus muscle, pain, and weakness.On 11/05/2020, clinical notes state the patient has been hearing a ¿squeal¿ noise in the hip.On (b)(6) 2020, the patient had a revision of the left hip to address pain, discomfort, elevated metal levels, and difficulties standing, sitting, walking, climbing stairs, and performing normal daily living activities.The patient also noted an inability to sleep.During the procedure, the surgeon observed extensive clear serious fluid, metallosis, pseudotumor, and debris.The head and liner were revised.(part/lot page 740 of 1448 on medical records ad 15 apr 2023) (b)(4).12/17/2020 lab value cobalt 7.1 ug/l, chromium 11.9 ug/l.01/11/2021 lab value cobalt 4.1 ug/l, chromium 9.4 ug/l.The medical records noted medical information on the knees with no manufacturer.No pc's required at this time.In 2005 bilateral tkr (no specifics).On (b)(6) 2018 office visit notes the patient has patellofemoral crepitus in the left knee.Imaging notes a slight amount of patella baja.On (b)(6) 2018 patient reported left knee pain, and it locked up on him.Radiograph interpretation noted there may be a piece of polyethylene shadow in the back on the left.On (b)(6) 2018 patient reports having left knee swelling, pain, and ¿locks up¿.On 04/16/2018 patient had a left total knee arthroplasty to address chronic pain of left (no surgical notes).

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL FEMORAL HEAD
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14162741
• MDR Text Key: 289690365
• Report Number: 1818910-2022-07150
• 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: 04/20/2022

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 Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 04/25/2022; 03/01/2023; 04/15/2023; 04/15/2023; 05/23/2023; 08/17/2023; 09/19/2023
• Supplement Dates FDA Received: 04/26/2022; 03/14/2023; 04/26/2023; 05/09/2023; 06/01/2023; 09/13/2023; 09/20/2023
• 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 PINNACLE.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male