STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ABG II V40 LONG NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number UNK_SHC |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
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Event Date 02/01/2022 |
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.Voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported event is considered to be under the scope of this recall.No further investigation is required.H3 other text : device not returned to the manufacturer.
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Event Description
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Patient underwent right thr on (b)(6) 2011.Abg ii modular hip system with an abg11 v0 long neck, abg11 modular stem n6 and ceramic v40 femoral head 36mm were implanted.In (b)(6) 2015/(b)(6) 2016, patient experienced symptoms in her right hip, thigh and knee.Revision surgery was performed on patient's right hip with proximal femoral bone grafting on approx 1/02/2022.Pt reports ongoing pain over right groin area, cobalt poisoning, metallosis, bone loss to proximal part of femur and restricted range of movement.
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Manufacturer Narrative
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Reported event: an event regarding pain involving a rejuvenate modular device was reported.The event was confirmed.Method & results: -device evaluation and results: device evaluation was not performed as no devices were received/ device remained implanted.-device history review: review of device history records could not be performed as the reported device was not properly identified.-complaint history review: a search of the complaint databases could not be performed as the reported device was not properly identified.Similar events have occurred for the rejuvenate modular product family.These events were determined to be associated with (b)(4).Conclusions voluntary recall (b)(4) was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported pain is considered to be under the scope of this recall.No further investigation is required.
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Event Description
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Patient underwent right thr on (b)(6) 2011.Abg ii modular hip system with an abg11 v0 long neck, abg11 modular stem n6 and ceramic v40 femoral head 36mm were implanted.In (b)(6) 2015/ (b)(6) 2016, patient experienced symptoms in her right hip, thigh and knee.Revision surgery was performed on patient's right hip with proximal femoral bone grafting on approx (b)(6) 2022.Pt reports ongoing pain over right groin area, cobalt poisoning, metallosis, bone loss to proximal part of femur and restricted range of movement.
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