ZIMMER BIOMET, INC. COMP PRIMARY STEM 15MM MINI; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES
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Catalog Number 113635 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Pain (1994)
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Event Date 05/27/2022 |
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: 0001825034-2022-01445, 0001825034-2022-01446.Concomitant medical products: item#: unknown, unknown head; lot#: unknown.Item#: 118001, versa-dial/comp ti std taper; 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 approximately 5 years post implantation, the patient underwent a revision due to pain and loosening of the stem component.Attempts for additional information have been made and none has been provided.
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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.D4: the definitive lot number of the stem could not be determined, it is either 278370 or 278320; d4: lot number - 278370 or 278320 d4: expiration date - jul 31, 2027 or aug 4, 2027 d4: (b)(4).H4 device manufacturer date - jul 31, 2017 or aug 4, 2017.H6: components codes: mechanical (g04) - stem.Visual examination of the provided pictures identified explanted products.An investigation was performed for both lot possibilities.However as the product was not returned further 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.Medical records were not provided.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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