Catalog Number 01.00191.250 |
Device Problems
Fracture (1260); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Fall (1848); Failure of Implant (1924); Deformity/ Disfigurement (2360); Joint Dislocation (2374); Foreign Body In Patient (2687); Joint Laxity (4526); Metal Related Pathology (4530)
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Event Date 01/17/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: item#: unknown cup; lot#: unknown; item name: unknown cup; item#: unknown screw; lot#: unknown; item name: unknown screw; item#: unknown screw; lot#: unknown; item name: unknown screw; g2: foreign - germany.G2: other - bfarm#: 03636/23.Multiple mdr reports were filed for this event, please see the associated reports: 0009613350-2023-00207.0009613350-2023-00408 0009613350-2023-00411 the device will not be returned for analysis; however, an investigation of the reported event is in progress.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 a patient with an extensive revision history underwent a revision with implantation of a burch-schneider support shell, due to a fracture of the posterior acetabular pillar.Subsequently, the patient experienced a traumatic fall and had a revision.During the surgery, macroscopic metallosis was noted with acetabular dislocation, loosening and posterior fracture of the burch schneider support shell, loosening of all screws, fracture of one screw, and the dorsal rim was found non-existent with a large defect centrally.Part of the fractured screw was left within the pelvic bone as it was noted the exposure time was too time consuming.Competitor product was implanted and the procedure was completed without complication.Due diligence is completed for this complaint; to date whatever additional information received has been captured in this report.
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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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.Of note is that patient consent was received.In the event that the products are returned, the complaint investigation will be re-assessed and updated.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of manufacturing records for the unknown cup and unknown screws cannot be performed without product identification.Devices are used for treatment.The surgical report for revision surgery was received and reviewed by the nurse review group (hcp) with the following potentially contributing factors of event: traumatic fall ; prior surgery with burch-schneider support shell for fracture of the posterior acetabular pillar ; hx dislocations; obesity.The following findings were observed by the nurse review group (hcp): metallosis of right hip with acetabular dislocation, loosening as well as fracture burch.Schneider support shell.No evidence of infection.Anterolateral modified approach.Macroscopic metallosis.Taper and stem well preserved.Loosely dislocated cup with loosened cement residues imbedded in the cup region- not captured as cup/cement is unknown.All screws are loose and one screw is broken.¿broken piece if left in pelvic bone since exposure is too time consuming and not necessary here¿.Shell- posterior region fractured (¿in sense of a material fracture¿).The dorsal acetabular rim is non-existent, as is a large defect centrally.Insertion of cancellous bone and femoral wedge into the cranial acetabular area for defect reconstruction.One preoperative radiographic image and one intra-operative fluoroscopic image were provided and reviewed by hcp (mmi - radiologist) with the following assessment: coned-down image of the right hip rontal image of the lower pelvis and proximal to mid bilateral femurs image 1 displays disassociation of the acetabular cup component, in which the cup is turned almost 90 degrees in the clockwise direction.The femoral head component is subluxed superolateral to the acetabulum.Image 2 demonstrates subluxation of the femoral head component which is eccentrically positioned superolateral with respect of the acetabulum.The acetabular cup appears lucent and rotated slightly clockwise resulting in severe increased lateral inclination of the acetabular cup.The acetabular cup is not dislocated out of the native acetabulum.Fracture of the salvage plate and screws within the acetabulum is not radiographically detected on either image.Acetabular cup implant disassembly and abnormal alignment of the femoral component with respect of the acetabular component.This could be due to metallosis as described on the event/deficiency description, although this can not be confirmed radiographically (better evaluated with cross-sectional imaging).Observation of the cup in the intraoperative fluoroscopic image does not appear to be a compatible product for the ring according to the surgical technique.It can therefore be assumed that an off-label approach was used during implantation.Based on the given information and the results of the investigation, it is likely that the reported fall event directly caused or contributed to the reported event.Possible contributing factors are the patient's medical/surgical history.Of additional note is that the observation of the cup in the intraoperative fluoroscopic image does not appear to be a compatible product for the ring according to the surgical technique and zimmer biomet product compatibility list.It can therefore be assumed that an off-label approach was used during implantation.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Manufacturer Narrative
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(b)(4).Updated on nov 13, 2023 due to product return and the receipt of medical documentation (cd containing ct scans).The burch-schneider reinforcement cage was returned to the post market surveillance team for examination.The reported event can be confirmed.There is an incomplete fracture of the cage at one of the latches/fins which spans through three of the screw holes.There are some patches of cement seen on the device.The non-anchoring side of the cage shows numerous scratches and polished surfaces as well as some discoloring.A cd containing 644 ct scans was received and reviewed by the nurse review group (hcp) with the following assessment: "cd reviewed in zip file, 644 ct on cd from 24-jan-2023.Images not of value due to scatter and poor image quality, sending these images would not enhance the investigation." the outcome of the investigation remains the same.This follow-up report is being submitted to relay additional information.
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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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Search Alerts/Recalls
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