Catalog Number 999800312 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Osteolysis (2377); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/24/2013 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.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.
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Event Description
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Litigation received alleging that the patient suffers from pain, discomfort, swelling, and immobilization and acute localized damage to tissue and/or bone surround the acetabulum and systemic injuries.Also alleged are an excessive level of chromium and cobalt.On (b)(6) 2014 plaintiff¿s preliminary disclosure form was received, which identified dob information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.On (b)(6) 2021 - after review of medical records, the patient was revised due to failed right tha, trunnionosis, osteolysis.Operative notes reported that there was significant wear debris and metallosis around the trunnion.The stem has a corroded trunnion and was removed.There was extensive osteolysis noted of the proximal femur.Multiple proximal fractures of the femur were noted in the areas of extensive lysis in the trochanter and anterior femur.Also due to the extensive osteolysis around the acetabular implant, posterior wall and ischial rim fractures were noted.It was also noted that the surgery was delayed for 4 hours.Doi: (b)(6) 2006.Dor: (b)(6) 2020.Right hip.
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Manufacturer Narrative
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Product complaint # : pc-(b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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 : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 clinical code: appropriate term / code not available (e2402) is used to capture unspecified tissue injury (e2015).
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Search Alerts/Recalls
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