STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Model Number 1236-2-852 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Bacterial Infection (1735)
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Event Date 09/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: delta v-40 ceramic head 28/-2,7 cat# 6570-0-328; lot#74257902.Size 5 accolade ii 132 deg cat# 6720-0535; lot#78367317.Modular dual mobility insert cat# 626-00-46f; lot# 75653404.Tridentii tritanium cluster58f cat# 702-04-58f; lot# 77385101a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
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Event Description
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As reported: "left hip revision due to superficial infection to rule out deep wound infection not related to implants according to dr." an adm/ mdm poly insert and biolox femoral head were revised.Rep provided the primary usage sheet and confirmed that no further information will be released.
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Search Alerts/Recalls
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