Model Number N/A |
Device Problems
Positioning Failure (1158); Fitting Problem (2183); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical products: medical product: delta cer fem hd 32/0mm t1, catalog #: 650-1162, lot #: 2019072437.Medical product: tprlc 133 t1 pps so 12x144mm, catalog #: 51-103120, lot #: 6663782.Medical product: g7 neutral e1 liner 32mm f, catalog #: 010000850, lot #: 6657095.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00165.Post code: (b)(6).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 the liner was not seating properly.Liner was removed, and a new liner was placed.No additional information provided.No delay of the procedure was reported.Not known impact or consequences to the patient or the user.
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Manufacturer Narrative
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(b)(4).G3: report source, foreign - event occurred in netherlands.D11: medical product: delta cer fem hd 32/0mm t1, catalog #: 650-1162, lot #: 2019072437; medical product: tprlc 133 t1 pps so 12x144mm, catalog #: 51-103120, lot #: 6663782; medical product: g7 neutral e1 liner 32mm f, catalog #: 010000850, lot #: 6657095.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00165-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history (liner has been discarded).A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: -cmp contains allegation of liner not seating.There are no details provided suggesting any issue with either the femoral head or shell and these remain implanted.The liner is part of associated complaint (b)(4).-no risk assessment can be conducted as there is no indication that either the cup or femoral head have presented a hazard/hazardous situation.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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Event Description
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It was reported that the liner was not seating properly.Liner was removed, and a new liner was placed.Implanted liner: model: 010000850, lot: 6657095.No delay of the procedure was reported.Not known impact or consequences to the patient or the user.
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Search Alerts/Recalls
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