Catalog Number 11-210043 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscular Rigidity (1968); Loss of Range of Motion (2032); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)
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Event Date 01/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).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.Product remains implanted.
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Event Description
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It was reported that the patient underwent an initial left orif, lateral ligament repair, and radial head replacement.Subsequently, post three surgical interventions within two years, the patient continues to experience difficulty with stiffness and range of motion without relief.No additional patient consequences were reported.
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Event Description
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No additional event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated:b4, b5, g4, g7, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.Radiographs were provided and the following results were identified: manipulation notes: 16-jan-2019; left elbow examination under the regional block with manipulation due to left elbow contracture elbow brought to full extension until adhesions were felt to lyse and release, able to achieve full extension, flexion to 145°, full pronation and supination to 80°, cortisone injections provided, procedure completed without complication (no product exchange) contributing factors of event: traumatic injury fracture-dislocation (terrible triad injury) left elbow orif with lateral ligament repair and radial head replacement previous open capsular release with manipulation previous arthroscopic lysis of adhesions root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
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Manufacturer Narrative
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D4: udi# (b)(4).D11: 11-210063 explor 8x28mm impl stem w/scr 561880 3322-020 depuy bone cement 8195909.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: 0001825034 - 2020 - 03709.
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Event Description
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No additional event information received at the time of this report.
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Manufacturer Narrative
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The events under complaints (b)(4) are a continuation of the same complication resistant to medical/surgical interventions, are within a short timeframe, and no product has been exchanged.This device has been reported under cmp-0581544 and medwatch# 0001825034 - 2020 - 00923 - 2.
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Event Description
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Upon receipt of additional information, it has been determined that this device has been reported as a duplicate.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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