Catalog Number P1700484 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Muscle/Tendon Damage (4532); Insufficient Information (4580)
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Event Date 04/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2-foreign- france.H3-other: device part# and lot# are unknown.Also device location is unknown.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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It was reported that after a fall on the shoulder, the patient underwent revision surgery due to unknown mechanical complications with the device.
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Event Description
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It was reported that the patient underwent revision surgery due to cuff lesion.Due diligence performed, all the received information was captured.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.D10.Item#:p1700484 ;lot#:unknown ;item name: tess hum centered head 43 ; item#:p1700440 ;lot#:unknown ;item name: hum anatomical corolla s0 ; item#:p1700331 ;lot#:unknown ;item name: tess glenoid cmtless bseplt s1; item#:p1700128 ;lot#:unknown ;item name: tess hum stem small.Multiple mdr reports were filed for this event, please see associated reports: 3006946279 - 2023 - 00121.3006946279 - 2023 - 00122.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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Initial right anatomic shoulder arthroplasty performed.Subsequently, the patient was revised due to cuff lesion four (4) years six (6) months after initial surgery.No further details or outcomes have been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The review identified avascular necrosis as contributing factor of the event.Moreover, patient fall on shoulder (b)(6) 2019, which led to the prosthesis replacement for mechanical reasons.The root cause of the reported issue is attributed to a patient accident (fall on his shoulder).As per instructions for use, falls are listed as factors which may compromise successful implantation and device performance.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.H3 other text : device location is unknown.
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Search Alerts/Recalls
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