ZIMMER BIOMET, INC. 12MM A 130MM LENGTH HUMERAL STEM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
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Model Number 00-4349-012-13 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994); Muscle Hypotonia (4531)
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Event Date 05/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02669, 0001822565-2022-02670, 0001822565-2022-02671, 0001822565-2022-02672, 0001822565-2022-02673.Concomitant medical products: item#: 00434903611, 36mm a glenosphere; lot#: 62234748.Item#: 00834902502, tm rvs base plt 25mm post +2; lot#: 62274777.Item#: unknown, unknown screw length 36; lot#: unknown.Item#: unknown, unknown screw length 42; lot#: unknown.Item#: unknown, unknown poly; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 a patient underwent a third revision surgery of their shoulder approximately six (6) years and three (3) month after their second revision surgery.The patient was revised due to pain, radiolucency, and loosening.The patient continues to display atrophy of the surrounding muscles.There were no other additional complications reported at this time.
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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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02670-1, 0001822565-2022-02669-1, 0001822565-2022-02671-1, 0001822565-2022-02672-1, 0001822565-2022-02673-1.Component codes: mechanical (g04)- stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Study reports were provided and reviewed by a health care professional.Review of the available records identified the following: pain noted beginning at on (b)(6) 2015 visit.Deltoid atrophy noted beginning at on (b)(6) 2015 visit.On (b)(6) 2018 visit noted anteroposterior and axillary xray: tricep calcification and humeral radiolucency; no planned intervention at this time.On (b)(6) 2021: revision of right total shoulder due to mechanical loosening & study complete due to device removal.A definitive root cause cannot 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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