ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED RIGHT 12MM HT; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: singapore.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.
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Event Description
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During the articular surface insertion, surgeon tried to implant a 12mm insert high into patient.The insert did look like it went down, however it is not fully flushed and there is no sound.Surgeon tried to install the surface multiple times, however it failed.The insert did not flush down onto patient even after trying to impact in.Surgeon initial wanted a 12mm height insert into patient, however it has been changed to 11mm.
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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, visual examination of the returned product identified found the distal surface to exhibit damage (impact marks) and the locking features to be flared out.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.Complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products ----------------------------------------- 42532006102 tibia cemented 5 degree stemmed right size b lot # 65281964 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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No further event information available at the time of this report.
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