ZIMMER BIOMET, INC. HUMERAL STEM 42 DEGREES 13 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, SHOULDER
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Model Number N/A |
Device Problem
Migration (4003)
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Patient Problems
Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)
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Event Date 08/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00430204652 glenoid component pegged 52 mm diameter articular surface used with white (46 mm) instruments 62890682, 00430205218 offset modular humeral head 18 mm head height 52 mm spherical head diameter 63081908.The complaint is under investigation.Once the investigation is complete a follow up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01265, 0001822565 - 2019 - 01268.
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Event Description
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It was reported that the patient underwent an initial left shoulder arthroplasty.The patient began experiencing limited range of motion/strength, a grinding sensation, and increased pain in the shoulder shortly following the initial procedure.The patient was subsequently revised approximately seventeen (17) months post primary implantation due to pain, tendon tear and lucency.No additional information is available.
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Event Description
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Upon reassessment of the reported event based on additional information, it was determined that the product is not reportable, hence the initial report submitted needs to be voided.
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Manufacturer Narrative
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Upon reassessment of the reported event based on additional information, it was determined that the product is not reportable, hence the initial report submitted needs to be voided.
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Search Alerts/Recalls
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