BIOMET ORTHOPEDICS VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD W/VARIABLE OFFSET; PROSTHESIS, SHOULDER SEMI-CONSTRAINED
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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Muscle Weakness (1967); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant devices: biomet compr nano hmrl pps 40mm item # us-115740 lot # 402850, biomet versa-dial/comp ti std taper catalog # 118001 lot # 482970, biomet lg hybrid glenoid base 4mm, catalog # 113956, lot # 816600, biomet pt hybrid glen post regenerex catalog # pt-113950, lot # 558340.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.This report is number 2 of 4 mdrs filed for the same patient (reference 0001825034-2017-04125 / 04132 / 04133 / 04134).
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Event Description
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It was reported that the patient underwent an initial shoulder arthroplasty procedure.Subsequently, as reported at the (6) six week post operative follow-up, the patient experienced pain, impingement, and mild coracoid process tenderness.At the three (3) month post operative follow-up, the patient experienced incision tenderness, pain, and mild instability.At the one (1) year post operative follow-up, the patient experienced impingement, instability, and continued mild pain.At the two (2) year post operative follow-up, the patient experienced left sided muscle weakness and coracoid tenderness.The pain reportedly resolved, however the muscle weakness is still ongoing.Attempts have been made to obtain additional information and further information is not available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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