STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Model Number 1236-2-854 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 06/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.
There have been no other events for the lot referenced.
The following devices were also listed in this report: tridentii tritanium cluster60g; cat# 702-04-60g; lot# 70081001a.
Modular dual mobility insert; cat# 626-00-48g; lot# 74323801.
Delta v-40 ceramic head 28/+4; cat# 6570-0-228; lot# 64377701.
Size 9 accolade ii 132 deg; cat# 6720-0937; lot# 69083902.
It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Event Description
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Procedure: patient underwent index tha on (b)(6) 2020.
Then the patient had a periprosthetic joint infection, so all components where exchanged in a one stage revision on (b)(6) 2020.
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Search Alerts/Recalls
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