Model Number 01.04555.130 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Unspecified Infection (1930); Osteolysis (2377)
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Event Date 09/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical devices: modular humeral head 30 mm head height 52 mm spherical head diameter; item# 00430005230; lot# 61194309; trabecular metaloc glenoid component 52 mm articular surface use with blue instruments & blue humeral head; item# 00432605200; lot# 63924825.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the patient underwent a shoulder replacement surgery and approximately 4 years later a revision to a spacer was performed due to infection and loosening.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures shows what appears to bone through-growth on the anchor fins, no further information can be gleaned from the photograph.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a right shoulder arthroplasty is present.There is no fracture or dislocation.There is extensive osteolysis involving the humeral and glenoid implant fixation with suspected implant loosening but no implant displacement.The extensive osteolysis present could be related to infection, but this is not certain.Regardless of the cause, this degree of osteolysis would lead to loosening.The root cause of the reported issue is attributed to non-device related infection leading to loosening.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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Search Alerts/Recalls
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