Catalog Number 14.28.05-20 |
Device Problems
Device Dislodged or Dislocated (2923); Unintended Movement (3026); Migration (4003)
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Patient Problem
Joint Dislocation (2374)
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Event Date 05/02/2023 |
Event Type
Injury
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Event Description
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It was reported that patient underwent implantation of a hip prostheses.Postoperatively during exercise, the head and liner disassociated resulting in hip dislocation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).G2-foreign- germany.D10.Item#:61.27.28-42 ;lot#:unknown ;item name: bipolar insert, modular, 42/28; item#:4712500398-3 ;lot#:axdj2502 ;item name: optipac 40 refob bone cmt r-3 ; item#:01.06010.203 ;lot#: 3119158;item name: avenir, stem, standard, cemented, 3, taper 12/14 ; item#:61.27.00-44 ;lot#:2996323 ;item name: bipolar shell, modular, 44; multiple mdr reports were filed for this event, please see associated report: 0009613350 - 2023 - 00292 investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that patient underwent implantation of a hip prostheses.Postoperatively during exercise, the head and liner disassociated resulting in hip dislocation, which required revision surgery.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b2, b4, b5, d6, g3, g6, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records for the cocr head confirmed no abnormalities or deviations that could be related to the reported event.A review of the device manufacturing records for the liner cannot be performed without product identification.Devices are used for treatment.The implant protocol for implantation surgery dated 2023 was received.Procedure performed was an implantation of a cemented bipolar prosthesis at the hip.The implanted products are provided.Of note is that the lot number of the liner is not provided.Based on the given information and results of the investigation, 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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Search Alerts/Recalls
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