DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX50OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
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Catalog Number 121887350 |
Device Problems
Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Unspecified Infection (1930); Itching Sensation (1943); Necrosis (1971); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Sepsis (2067); Tissue Damage (2104); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)
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Event Date 04/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).
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Event Description
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Pinnacle litigation records received.Litigation alleges toxic cobalt-chromium metal debris to be released into patient's soft tissue surrounding the implant.The patient began to have difficulty with normal everyday tasks, experienced extreme pain, difference in leg length made walking difficulty and there was also a grinding sensation present while walking.Sitting and standing caused her extreme discomfort.The surgeon informed her that she had elevated metal ions.During revision surgery it was discovered that the implant had caused significant metallosis in the soft tissues and blackened discolored tissue throughout the hip.Doi: (b)(6) 2007: dor: (b)(6) 2018 (right hip).
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Manufacturer Narrative
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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, a follow-up medwatch will be filed as appropriate. .
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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. udi: (b)(4).
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Event Description
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Pff alleges metal wear, metallosis and elevated metal ions.After review of medical records, patient was revised to address pain due to prosthetic infection and metallosis without loosening and with retroacetabular and limited proximal femoral osteolysis.It was also reported of minor posterior edge greater trochanter fracture and medial wall acetabular fractures.Added expiration date, manufactured date, product and lot details of head and liner.Added manufactured date, product and lot details of stem.Added patient age and dob.Updated patient initials.
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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.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 : 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. additional narrative: added: (patient codes).
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Event Description
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Patient communication received.As stated " received a metal on metal hip replacement 2006.Went for 12 years to multiple doctors who refused to take care of me.Severe worsening pain from the day it was placed until 2018.In this time i experienced pain, neuropathy, rashes, itching,anxiety ,depression,cognitive issues.Made fun for years because of the noises the hip made with every step.All doctors ever did were x-rays and they always stated the hip was in place.The fda allowed this device into the market and i have been severely injured and have lifelong disabilities because of the metal on metal hip.Now, completely unable to return to my career as a registered nurse,metal levels over 49,sepsis, pseudotumors, necrosis and bone loss.Antibiotic spacer placed 2018 for over 8 months and revision on 2018.All completed at medical center".
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Search Alerts/Recalls
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