Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial report.Report source, foreign - event occurred in the (b)(6).As the source is a journal article the current whereabouts of the device is unknown.Due diligence is taking place to locate the device for analysis if possible.The investigation is currently underway.Once the investigation has been concluded, a follow-up report will be submitted to relay the findings.
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Event Description
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It was reported, that: on 04 march 2022, a journal article was retrieved from the journal of clinical orthopaedics and trauma (2020) 11 supplement 2 (s265-s269) that reported a study from the uk.The purpose of this study is to evaluate the medium-term outcomes and survival of the copeland resurfacing hemiarthroplasty of the shoulder (crha) and compare these for the major underlying pathologies in a consecutive series of patients in an independent centre.A retrospective cohort study was performed.Inclusion criteria were all crhas implanted in a single hospital trust between january 2002 and july 2016.No patients were excluded.All patients had completed a minimum of 12 months of nonsurgical management comprising oral analgesia, intra-articular corticosteroid injection and physiotherapy.Crha remains a reasonable option for oa in patients with an intact rotator cuff and with sufficient bone stock, especially in those aged over 65 years.With poorer functional outcomes and survival, crha should not be offered in those with cta (rotator cuff tear arthropathy).The study reported that a patient underwent a revision procedure for aseptic loosening resulting from avn (avascular necrosis).Patient outcome: revision.
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Event Description
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It was reported, that: on (b)(6) 2022, a journal article was retrieved from the journal of clinical orthopaedics and trauma (2020) 11 supplement 2 (s265-s269) that reported a study from the uk.The purpose of this study is to evaluate the medium-term outcomes and survival of the copeland resurfacing hemiarthroplasty of the shoulder (crha) and compare these for the major underlying pathologies in a consecutive series of patients in an independent centre.A retrospective cohort study was performed.Inclusion criteria were all crhas implanted in a single hospital trust between (b)(6) 2002 and (b)(6) 2016.No patients were excluded.All patients had completed a minimum of 12 months of nonsurgical management comprising oral analgesia, intra-articular corticosteroid injection and physiotherapy.Crha remains a reasonable option for oa in patients with an intact rotator cuff and with sufficient bone stock, especially in those aged over 65 years.With poorer functional outcomes and survival, crha should not be offered in those with cta (rotator cuff tear arthropathy).The study reported that a patient underwent a revision procedure for aseptic loosening resulting from avn (avascular necrosis).Patient outcome: revision.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: date of the initial procedure: (b)(6) 2006.Date of the revision procedure (b)(6) 2008.Gender: male.Age: 40 at time of revision.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported, that: on 04 march 2022, a journal article was retrieved from the journal of clinical orthopaedics and trauma (2020) 11 supplement 2 (s265-s269) that reported a study from the uk.The purpose of this study is to evaluate the medium-term outcomes and survival of the copeland resurfacing hemiarthroplasty of the shoulder (crha) and compare these to the major underlying pathologies in a consecutive series of patients in an independent centre.A retrospective cohort study was performed.Inclusion criteria were all crhas implanted in a single hospital trust between january 2002 and july 2016.No patients were excluded.All patients had completed a minimum of 12 months of nonsurgical management comprising oral analgesia, intra-articular corticosteroid injection and physiotherapy.Crha remains a reasonable option for oa in patients with an intact rotator cuff and with sufficient bone stock, especially in those aged over 65 years.With poorer functional outcomes and survival, crha should not be offered in those with cta (rotator cuff tear arthropathy).The study reported that a patient underwent a revision procedure for aseptic loosening resulting from avn (avascular necrosis).Patient outcome: revision.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.This device is used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the device when it left zimmer biomet could not be determined as the item and lot number have not been provided.The root cause of the reported event can not be determined with the information provided no corrective action is required at this time as the root cause of the reported event has not been determined if any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be tendered accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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