SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +0; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/PLYMR,CMNTD OR NON-POROUS,UNCMNTD
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Model Number 71343200 |
Device Problem
Scratched Material (3020)
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Patient Problem
Injury (2348)
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Event Date 04/08/2020 |
Event Type
Injury
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Event Description
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It was reported that during surgery, liner (71332754) was implanted and when trial head (75100856) was done being used to make surgical assessment of length and offset, scratches were noticed on liner.Since no backup device was available, a liner with different size was used to complete the procedure (71339554).Once the stem and head (71343200) were implanted, as surgeon was trying to remove the head, stem and head were removed as one piece and scratches were noticed on the oxinium head.Procedure was completed with a backup device of the same size for the head.A delay of less than 1 hour was reported.
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Manufacturer Narrative
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Additional information: b5.
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Event Description
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It was reported that during surgery, liner (71332754) was implanted and when trial head (75100856) was done being used to make surgical assessment of length and offset, scratches were noticed on liner.Since no backup device was available, a liner with different size was used to complete the procedure (71339554).Once the stem and head (71343200) were implanted, as surgeon was trying to remove the head, stem and head were removed as one piece and scratches were noticed on the oxinium head.Procedure was completed with a backup device of the same size for the head.A delay of less than 1 hour was reported.
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Search Alerts/Recalls
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