ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 10; PROSTHETIC, HIP
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104)
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Event Date 11/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: item# 00877503601 | item name: biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14 | lot#3013180.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03994, 0002648920 - 2020 - 00515, 0001822565 - 2020 - 04005.
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Event Description
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It was reported a patient had an initial right total hip arthroplasty.Subsequently, the patient was revised approximately 4 months later due to pain, difficulty ambulating, and tissue damage.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Additional mdr report was filed for this event, please see associated reports: 0002648920 - 2020 - 00526.
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Event Description
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It was reported a patient had an initial right total hip arthroplasty.Subsequently, the patient was revised approximately 4 months later due to pain, difficulty ambulating, and tissue damage.There was nothing wrong with the screws themselves, they were just placed in a position that was causing soft tissue irritation and were, therefore, removed.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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Upon reassessment of the reported event, the stem was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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Upon reassessment of the reported event, the stem was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
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