STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Model Number 626-00-42E |
Device Problem
Corroded (1131)
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Patient Problems
Foreign Body Reaction (1868); Unspecified Infection (1930); Osteolysis (2377)
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Event Date 08/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Metal mdm liner developed black film due to metallosis at liner/cup interface.A culture was taken preoperatively indicating infection.Patient developed metallosis from cocr liner.Posterior pseudo capsule removed due to metal materials.Unsure whether patient will have any long-term effects.Also, osteolysis developed around the cup, as well as a large cyst in the posterior superior aspect of acetabulum.A (non-stryker) biologic was injected into the cyst, which ejected out of the posterior of the acetabulum and into the bladder.Unclear whether that was the result of osteolysis from the liner or improper application by the surgeon of the biologic.
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Search Alerts/Recalls
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