ZIMMER BIOMET, INC. HUMERAL STEM 18 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS SHOULDER
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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); Disability (2371)
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Event Date 10/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(udi): n/a.Medical product: catalog #: 00434903611, glenosphere 36 mm diameter, lot # 63736820; catalog #: 00434901500, base plate 15 mm, lot # 63755874; catalog #: unknown, unknown 9mm humeral spacer, lot # unknown; catalog #: unknown, unknown poly liner, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02758, 0001822565-2020-02759, 0001822565-2020-02760, 0001822565-2020-02761.Remains implanted.
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Event Description
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It was reported that a patient underwent an initial right reverse tsa approximately 3 years ago due to a massive irreparable rotator cuff tear.He subsequently underwent two revision surgeries each one month later.The patient¿s is giving allegations of ongoing permanent injury, loss of use of right shoulder, and disability.There is no additional information available at this time.
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Manufacturer Narrative
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(b)(4).Updated: b4, b5, d4(udi), g4, h1, h2, h3, h6, h10.Reported event was confirmed via medical notes which stated that the patient had virtually no active forward elevation, only 30 degrees in supine position, cannot hold arm up at 90 degrees, suspected axillary nerve not functioning properly.This was after the revision and 8 months of physical therapy.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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