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DEPUY ORTHOPAEDICS, INC. 1818910 6IN AML SM STATURE 12.0MM; AML IMPLANT : HIP FEMORAL STEM
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| Catalog Number 155401121 |
| Device Problems
Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Host-Tissue Reaction (1297); Fatigue (1849); Foreign Body Reaction (1868); Granuloma (1876); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Muscular Rigidity (1968); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Thrombosis (2100); Tissue Damage (2104); Hypoesthesia (2352); Numbness (2415); No Code Available (3191); Balance Problems (4401); Paresthesia (4421); Thrombosis/Thrombus (4440); Metal Related Pathology (4530); Swelling/ Edema (4577)
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| Event Date 12/14/2017 |
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Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Pinnacle litigation record received.Litigation record alleges pain and swelling, numbness, tingling along the lateral and medial thigh, foot drop, pseudotumor and high levels of chromium and cobalt in plaintiff's blood.Doi: (b)(6) 2009 ; dor: (b)(6) 2017 (right hip).
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Manufacturer Narrative
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Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Udi: (b)(4).
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Event Description
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Ppf alleges pseudotumor, metal wear and elevated metal ions.Added account name, dob and associated contact.Updated unknown liner, head and stem in impacted products.
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Manufacturer Narrative
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Product complaint # (b)(4).
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Event Description
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In addition to what were previously reported, pfs reported dvt, metal reaction and infection.After review of medical records no further allegations were noted.
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Manufacturer Narrative
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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.Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).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. h10 additional narrative: added b6, b7, and h6 (patient code).No code available (3191) is used to capture (medical device removal).
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Manufacturer Narrative
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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.Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.
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Manufacturer Narrative
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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 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: e3, h6 (clinical and impact codes).E3 initial reporter occupation: lawyer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, g1.
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Manufacturer Narrative
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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: a5, a6 and b7.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available photo evidence was reviewed and does not shows an implant bearing wear (deterioration/discoloring) or any indicative related to a device nonconformance.Based on the information provided as evidence, a defect or malfunction cannot be established.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Manufacturer Narrative
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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.
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Event Description
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Medical records received.In addition to what was previously alleged, pfs alleges swelling, dvt, foot drop, lack of mobility, pseudotumor and metal reaction.After review of medical records patient was revised due to adverse local tissue reaction, sciatic nerve palsy, pseudotumor and abductor deficiency.Mild trunnionosis was noted after the head was removed.Implants used during revision were competitor products.It is unknown that during the left tha in 2003 were involved depuy products.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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(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: h6 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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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.
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Event Description
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Medical records received.After review, these are the following clinical visit: (b)(6) 2022 clinical visit: pt states she is still having pain in r leg and she had a hard time sleeping again last night.Reports she is still hurting in her shoulders and has trouble moving r shoulder.1/24/2023: pt states her leg is still hurting today, but not as bad as it has been recently.Reports she is still taking pain meds for decreasing pain in r thigh on her hematoma.States she is trying to use ice and rest arms, but she needs arms when moving in wheelchair.1/26/2023: pt states r leg pain has gotten worse again and there is an area on her posterior heel that the dermatologist is keeping an eye on.Pt notes that when she takes her pain meds it doesn't seem to help much.Pt continues to walk as little as possible d/t b shoulder pain (5/10).However, despite everything at r le, it has greatly decreased swelling throughout (pt has focused on keeping le elevated).Pt has not yet received her hinged bilateral support lockout brace for right knee to assist with the stability.1/31/2023: pt reports she is having pain in b shoulders and r leg again today.States she is not getting up and walking with walker because of pain in arms and r leg.2/2/2023: pt states she is having increased pain in her r leg today and she had a hard time sleeping last night.Reports she is still having pain in b shdrs with movement and use of wheelchair.2/16/2023: pt states she did not sleep much last night and her r leg is really hurting today.Reports she is still unable to use her arms with standing very long because her shdrs are hurting so much.Reports she is using tens unit for shdrs to try and get pain down in her arms.Medical records ad 17 may 2023 were reviewed by a clinician.The records detail a series of 58 physical therapy visits dated from (b)(6) 2022 to (b)(6) 2023.The physical therapy visits address the patient's left lower extremity tightness and weakness, right lower extremity lymphedema secondary to "metallosis", a hematoma on the right thigh, decreased balance, and pain in the right leg.
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Manufacturer Narrative
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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.
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Event Description
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Medical records received.In 2009, the patient had a right total hip arthroplasty.Aug 2016, the patient had right total knee, after surgery the patient developed right anterior thigh pain and swelling, numbness and tingling along the right lateral and medical thigh and a progressive foot drop.(no mfg of knee provided, or surgical notes in the medical records reviewed.No new pc required at this point).On 01/2017 patient developed right femoral and popliteal dvt, which was treated with xarelto.On (b)(6) 2017, the patient had an aspiration of right hip, which was reported to show a white blood cell count of (b)(4) an da negative gram stain and culture.A biopsy of the right hip mass demonstrated fat and fibrosis, fibrous necrosis without infection or malignancy.On 10/04/2017, medical records note clinical concerns is integrity of femoral artery and veins and relation to synovial expansion patient with adverse local tissue reaction.Mra of lower extremity right reports finding synovial expansion with thickening and debris, consistent with adverse local tissue reaction, with surrounding muscular edema.No pseudoaneurysm, the femoral vein appears somewhat attenuated, likely related to an element of compression secondary to the aforementioned tissue reaction.Labs note cobalt 14.3 and chromium 2.9.12/11/2017 lab results: chromium 2.2 ug/l.12/13/2017 cobalt 5.3 ug/l.On (b)(6) 2017, the patient had a right hip exploration of sciatic nerve with neurolysis, exploration of femoral nerve and femoral nerve neurolysis, resection of pseudotumor of the right hip, to address pseudotumor, status post total hip replacement, metallosis, sciatic nerve compression, femoral nerve compression.Revision total hip replacement both components right.During the procedure, the surgeon observed a fibrous tumor, metallosis, pseudotumor.The specimen also was noted to contain tissue samples that were completely necrotic with a few areas that show marked chronic inflammation with ill-defined granulomas.The history of the patient¿s present illness included that the patient had developed paralysis of the right leg from the distal thigh down.It first presented as foot drop then progressed about the knee approximately 7 months ago.Competitor components were implanted during this procedure.Post surgery, the patient became anemic and was transfused 1 unit of prbc on pod#2 (part/lot page 530 of 967 competitor products) (surgery page 505 of 967).It should be noted that at this time, depuy cup, liner, femoral head were revised and replaced with competitor components.Lab specimens note that right hip hardware noted as depuy pinnacle ultament implant composed of 50 mm spiked acetabular cup with metallic liner and a 36 +1.5 mm metallic femoral head serial #: (b)(6)were part of the specimens removed.((b)(4)).On (b)(6) 2018, the patient underwent an explantation of right total hip arthroplasty, insertion of antibiotic spacer, irrigation and debridement, elevation of previous flap to address periporsthetic joint infection, previous metal on metal reaction with complete loss of abductors, right hip preoperative femoral and sciatic nerve palsy irrigation and debridement hip right, explant with antibiotic spacer placement, flap closure.It should be noted that depuy femoral stem was revised during this procedure along with the competitor products.During the procedure, it was noted that there was an inadvertent fracture of the tip of the greater trochanter because of avascular bone.Lab specimen from surgery included: femoral and acetabular components consisting of a modular metallic femoral stem with a collar, a tripolar oxidized zirconium and metallic coated polyethylene femoral head, with polyethylene acetabular liner with a metallic ring, and a metallic acetabular cup, and one metallic screw.Inscription on inner femoral head is 71342200, acetabular cup 5090256e and femoral stem d155401c.Ct scan of right hip notes findings of periprosthetic infection in the settling of right total hip arthroplasty with a large joint effusion decompressing into the adjacent soft tissues.A focal fluid collection is present just lateral to the gluteal musculature and then additionally fluid and gas extends further inferiorly just deep to the fascia lata extending inferiorly to withing 3.5 cm of the inferior tip of the femoral stem.Post operative radiograph are reported to show cerclage cables at the proximal right tibial shaft and multiple opaque beads overlying the right hip.Competitor products were implanted during this procedure.(surgery page577 of 967) (part/lot page 608 of 967) (b)(4) update).On (b)(6) 2018 revision hip exchange cement competitor spacer right.Competitor components were placed during this procedure.(surgery page 686 of 967) (part/lot page 710 of 967 ) (no pc).On 10/10/2018 radiograph right hip spacer, present with anatomic alignment.There is chronic osteolysis of the medical wall of the acetabulum unchanged from (b)(6) 2018.On 11/01/2018, the patient had a re-implantation right proximal femur replacement, total hip arthroplasty.Competitor components were implanted during this procedure.(surgery page 872 of 967) (part/lot page 904 of 967) (no pc).On 11/08/2018 patient completed a course of iv antibiotics for right hip mssa spacer infection (continuation, no pc).On 06/20/2019 patient was having a preoperative medical evaluation for right tkr revision.Patient reports pain, swelling, instability.Wound class is clean.Components implanted, including competitor cement.Are competitor product.Part/lot page 89 of 967.Specimen from surgery included: cemented metallic femoral component and a cemented metallic tibial component with hemi condylar polyethylene insert.Inscription on the tibial component 0379819 (no pc) on 02/21/2021 acute changes to right lower extremity over past 3 days including decreased sensation and color changes of her foot and ankle.1on 2/08/2021 medical records note the patient felt like their right knee revision may be loose and they could not walk, but was using a wheelchair due to significant pain, swelling, and increasing inability to bear weight.(competitor, no pc).(b)(6) 2023 patient passed away due to a clot that traveled to her aorta.No other info provided.
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Manufacturer Narrative
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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.
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Event Description
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Updated event description: the patient presents abdominal pain, diarrhea, and pain in her legs.She has a history of both venous and arterial clots in her right leg and states her left leg felt cold and was painful to move when she got up to use the bathroom.She does have partial paralysis of the right leg due to a failed hip replacement in (b)(6) 5-6 years ago.Denies vomiting, fever, and chills.She is on plavix and xarelto.Denies back pain.
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Manufacturer Narrative
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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.
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