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| 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 04/07/2017 |
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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 the patient underwent a left elbow arthroplasty.Subsequently, the patient underwent an open capsular release and manipulation of the joint due to stiffness and a loss of range of motion.While under anesthesia, the posterior capsule was released of scar tissue, and the joint was taken through full range of motion.No product was exchanged.
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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 confirmed by review of radiographs and medical records.The provided report identifies the alignment of the radial head and capitellum of humerus is maintained.The radial implant stem is not centrally positioned within the proximal radius and radiolucency at the most proximal bone/metal interface is noted.The bone quality is osteopenic.Review of medical records identified the following: medical records on (b)(6)2017 : - patient reports ongoing difficulties with stiffness since radial head replacement - no obvious swelling or deformity noted - rom 80-110° flexion, 30° arc of prosupination - neuro exam intact - no abnormalities noted on x-ray medical records on (b)(6)2017 : - left elbow open capsular release for stiffness extension contracture - preop rom 20-90° and supination of 30° - tourniquet time 29 minutes - posterior capsule extensively scarred, 1cm of olecranon resected, elbow manipulated with full rom and supination to 60-70° - procedure completed without complication, no product exchanged, sling to be used for several days - posterior release only, no anterior release 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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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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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 previously reported under (b)(4), medwatch# 0001825034 -2020 - 01260 - 1 and the report is being processed as a duplicate of this event.
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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 performed on an unknown date (b)(6) 2016.The patient underwent an open capsular release and manipulation of the joint on (b)(6) 2017 due to stiffness and a loss of range of motion.After cpm use, the patient reported rom reverted to pre-intervention status.A third manipulation was performed closed under anesthesia on (b)(6) 2019.Despite medical and surgical interventions, the patient continues to experience difficulty with stiffness and range of motion without relief.No product has been exchanged to date.
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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, h3, h6, h10.Device history record (dhr) was reviewed and no discrepancies were found.Reported event was confirmed by review of radiographs and medical records.Medical records were provided and review of the available records identified the following: (b)(6) 2017: patient reports ongoing difficulties with stiffness since radial head replacement.No obvious swelling or deformity noted, rom 80- 110 flexion, 30 arc of prosupination, neuro exam intact.X-ray review: no abnormalities noted.Plan for surgical intervention.(b)(6) 2017: patient reports having difficulty maintaining rom achieved from manipulation (50 arc, 90 flexion, 30 supination), neuro exam normal.Seeing pt multiple times throughout the week.(b)(6) 2017: no issues with the wound, has been performing rom exercises and dynamic splinting, pain controlled, not taking narcotics.Rom 30- 90 flexion.Local anesthetic provided for exam and manipulation.X-rays reviewed and showed no new complications, suture anchor in place.(b)(6) 2017: still has the restriction of motion but appears to be somewhat improving with pt, 40 extension with arc of motion 60.Ongoing pt, return in 6 weeks.(b)(6) 2017: patient fitted with brace to improve rom.Rom 30 extension, 3- 100 flexion, plan for continued therapy.From (b)(6), (b)(6) 2017, patient reports continued stiffness particularly in flexion, regained most of his extension, cannot reach his mouth with his left arm due to stiffness.Rom 20-90, 70 pronation, 40 supination.Spasticity of the triceps with several beats of clonus when attempting to flex.(b)(6) 2018 arthroscopic surgery to again remove scar tissue and possible bone fragments as well as capsule release, again able to extend and flex perfectly while under anesthesia, placed on cpm postop to improve rom.Placed on cpm follow (b)(6) 2018 surgery for 2 weeks, rom improved to 115 flexion and 15 extension.From (b)(6) 2019, left elbow examination under 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).From (b)(6) 2019, rom 10-85, placed in a hinged brace, will follow up in 4 weeks.Patient states in summary that after this manipulation, rom reverted back to pre-op status, now seeking another specialist (#6) to review case.Radiographs were provided abd review of the available records identified the following: ap view of (b)(6) 2017 demonstrates a cemented radial head replacement and a suture anchor at the lateral epicondyle of the humerus.In this single view, alignment is maintained.Ap and lateral views dated (b)(6) 2017 demonstrate osseous remodeling of the proximal radius near the radial implant stem.The stem is not aligned with the cement or the central canal of the proximal radius.Lucency is present at the most proximal bone-metal interface, which may be normal, but this could be confirmed by comparison with earlier images.A small amount of ossification is present anterior to the distal humerus and possibly within the joint space, representing either a coronoid fracture fragment or heterotopic ossification.Root cause was unable to 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 additional event information is available at the time of this report.
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Search Alerts/Recalls
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