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Model Number N/A |
Device Problems
Unstable (1667); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Fall (1848); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651)
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Event Date 03/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: cat# 30103604 lot# 64797272 g7 vit e neutral lnr 36mm d.Cat# 00877503601 lot# 3031184 biolox⮠delta, ceramic femoral head, s, 㸠36/-3.5, taper 12/14.Cat# unknown lot# 838baf1806 refobacin bone cement.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 01038 the customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 patient underwent an initial right hip arthroplasty.Subsequently the patient reported a fall occurred on an unknown date and experienced pain and instability.Imaging revealed nonunion of greater trochanter fracture.The patient underwent a revision approximately 2.5 years after initial surgery.The shell was retained, as noted to be well fixed.Surgeon confirmed aspectic loosening at cement mantle, and patient had been experiencing anterior and posterior impingement.Attempts have been made and no further information has been provided.
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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 {update/corrected}.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed.It was reported the patient fell due to unknown reasons and then reported pain, instability, noise, and discomfort.A revision was performed on where it was confirmed the stem was confirmed to have subsided and loosened.No immediate complications were noted.The head, stem, and liner were explanted and replaced.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic lucency surrounding the cemented component of the arthroplasty appears to be consistent with the reported history of aseptic loosening.It was reported the patient fell and began experiencing symptoms.However, as the reason for the fall is unknown, a definitive root cause cannot be determined.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
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No further information at the time of this report.
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Search Alerts/Recalls
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