Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).D10: 51-105130 item name tprlc xr t1 pps 13x146mm lot # 6820319 51-105170 item name tprlc xr t1 pps 17x154mm lot # 7136699 g2: foreign: japan multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2024 - 00294 0001825034 - 2024 - 00295 customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : device in process to return.
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Event Description
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It was reported that when inspecting the product, the sterile packaging was found damaged.There is no additional information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4.D9.G3.G6.H2.H6.H10.Visual evaluation of the returned product identified damage to the sterile packaging (blister).Sterility has been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.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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Event Description
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There is no update to the prior event description provided.
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Search Alerts/Recalls
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