SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR STANDARD TI/HA 3 (US); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Model Number 71335548 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hip Fracture (2349)
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Event Date 04/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from a post-market clinical follow-up activity that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
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Event Description
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On the pmcf titled dca-1000 accord ss clinical dataset, it was reported that, after undergoing left tha, one (1) patient experienced unspecified events that led to a revision surgery combined with internal fixation.This surgery was performed on (b)(6) 2021, in which an intraoperative femur fracture occurred.As remedial action, an accord cable system was implanted.A post-operative follow-up confirmed a good position without complicating features.
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Manufacturer Narrative
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Correction: (b)(4).Initial complaint was created against r3 3 hole acet shell mm48; a case re-assessment determined that, since a femur fracture occurred, complaint must be against the femoral stem.Corrected data: d1/d2a/d2b: brand name, product code.D3: manufacturer name, city and state.D4: catalog number, lot number, expiration date, udi.D10: concomitant medical products.Contact office: manufacturing site.G3 / g4: pma/510(k)number.H4: device manufacture date.
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