ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING (PS) LEFT 13 MM HEIGHT; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Associated products : item#: 42512400212; articular surface fixed bearing (ps) left 12 mm; lot#: 63882917; item#: 42512400214; articular surface fixed bearing (ps) left 14 mm; lot#: 64078599; item#: 42532006101; tibia cemented 5 degree stemmed left size b; lot#: 63846640; item#: 42500605601; psn fem ps cmt ccr std sz 4 l; lot#: 64766049.Foreign : (b)(6).Customer had indicated that the product was being returned to zimmer biomet for investigation, but it has not yet been received.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 02856, 0001822565 - 2021 - 02859.
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Event Description
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It was reported that during an initial tka, the 13 mm persona ps surface would not fixate onto the tibial stem.Two other persona ps surfaces were trialed, 12mm and 14mm, and were also unable to be fixed onto the tibial stem.Alternatively, a 16 mm articular surface was used to complete the procedure.There was a delay of 16-30 minutes, with no consequence to the patient.Attempts have been made and no additional information has been provided.
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Event Description
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No additional information 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: b4, b5, d9, g3, h1, h2, h6 the reported event was confirmed by examination of the returned device.Visual inspection showed that the dovetail feature is slightly flared and the device exhibits signs of use, nicks and gouges.Review of the device history records identified no deviations or anomalies during manufacturing.A root cause could not 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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