Model Number 1365-50-000 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling (2091); Distress (2329); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Occupation: lawyer.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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The patient was revised for irrigation & debridement for possible infection.Original implant date unknown.Doi: unknown; dor: (b)(6) 2019; left hip.
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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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : a complaint device manufacturing (dhr) reviews will not be performed.Per wi-3430 it has been determined that should related reports be identified a dhr review is not required.
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Event Description
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Patient alleges elevated metal ion, suffered injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.As a direct and proximate result, patient suffered pain, injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, economic loss, emotional trauma and distress, mental anguish, immobility, permanent instability and loss of balance, and physical disability.
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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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.Health effect clinical code: appropriate term / code not available (e2402) used to capture the metal poisoning and blood heavy metal increased.
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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.H6 clinical codes: swelling/ edema (e2338) is used to capture swelling and edema.Metal related pathology (e1618) is used to capture metal poisoning and blood heavy metal increased.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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After review, the patient had a hematoma on left greater trochanter.
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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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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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 were received and stated the following: on (b)(6)2019 patient presented to the emergency department due to severe left hip pain.The patient states the pain is 10 out of 10 shooting aching pain that started last night with significant bruising patient denies falling and injury.She states she had left total hip replacement with dr.Lawrence 6 months ago and she had a similar episode of pain, bruising, and swelling 2 months ago when she was diagnosed with a hematoma.The patient states pain gets worse with walking and she has radiation of pain down to her left calf.She is unable to ambulate due to pain.However, there was no scheduled revision.Doi: (b)(6)2008.Dor: (b)(6)2019 left hip.
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Manufacturer Narrative
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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.In order to observe implant wear a photo of the explanted device is required.Nothing indicative of a malfunction that could have contributed to the reported event were identified, additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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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Event Description
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Medical records received: on (b)(6) 2008, the patient had a left total hip anterior approach to address degenerative joint disease.Depuy pinnacle cup, metal insert, femoral head, corail, and apex hole eliminator.On (b)(6) 2019 the patient had an mri, it was reported to show left hip had an increased signal most prominent in the region of the greater trochanter of the femur and also in the acetabular region.There was no fracture of bone noted.Alval was present.On (b)(6) 2019 patient had a left total hip revision, head/liner exchange for mom pseudotumor, metallosis.Prior to surgery, it was noted that the patient had limited activity, limited mobility, and pain.Metal on metal components were revised to poly to femoral head.Intraoperative findings included pseudcyst, metal staining on the back of metal liner, depuy poly liner, depuy metal head were implanted during this procedure.(sticker page 1821 of 2824) legal document alleges elevated metal levels, pain, discomfort, difficulties standing, sitting, walking, climbing stairs, and performing normal daily living activities, inability to sleep and diminished quality of life.
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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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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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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 ad 17 jan 2024 received: page 4: on (b)(6) 2023, patient was seen in the clinical setting for reported patient fall resulting in patient "hurting her knee" with no additional details provided.There is no evidence of musculoskeletal or skin issues per the physical exam.The patient's pain scale rating is reported to be 8 (the actual details of the scale are not provided).Page 41: on (b)(6) 2022, patient was seen in clinic for migraine headache (no indication it was at all related to patient's extremity joints, but was stated to be probably sinusitis related.Patient also complained of left knee pain, without further details.Patient indicated also that she was waiting for a total left shoulder repair, postponed due to covid-19.Page 48: on (b)(6) 2020, patient was "seen" in clinic via telehealth, and discussed that she had seen an orthopedic surgeon for her back, for which she was diagnosed as having a large amount of arthritis and deterioration.Her cardiac status was poor though, so surgery at that time was not an option--therapy was the treatment she was going to proceed with in lieu of surgery.Page 401: same as report from page 4.On (b)(6) 2023, patient was seen in the clinical setting for reported patient fall resulting in patient "hurting her knee" with no additional details provided.
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Search Alerts/Recalls
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