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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Blood Loss (2597)
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Event Date 02/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00625006540, bone scr 6.5x40 self-tap, 61013586.00620005422, shell porous with cluster holes 54 mm o.D., 61008584.Item #: unknown, unknown stem, lot #: unknown.Item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown sleeve, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0002648920 - 2019 - 00769, screw.0002648920 - 2019 - 00763, cup.0001822565 - 2019 - 04570, stem.0001822565 - 2019 - 04571, head.0001822565 - 2019 - 04573, sleeve.
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Event Description
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It was reported that an initial right total hip arthroplasty performed and subsequently underwent revision seven years later of the head and liner due to complications from trunnionosis.The patient underwent a second nine years post initial due to pain, wound complications, and radiolucency with apparent acetabular screw fracture on x-ray.Prior to the revision, the patient underwent a venogram with stenting of the right external iliac vein due to the loose shell occluding the vein.During the revision, the acetabular component was noted to be grossly loose and freely floating within the joint space.Additionally, three soft tissue suture abscesses were noted and excised.The head, liner, and shell were replaced and antibiotic cement beads were placed within the joint.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d11, g4, h2, h3, h4, h6.D11: 00620005422, cup, lot no.61008584 00625006540, bone screw, lot no.61013586 00786201350, femoral stem, lot no.07886766 unknown ceramic head, lot no unknown reported event was confirmed by review of medical records.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.Revision op notes identified patient revised on due to pain, swelling, and elevated chromium levels.During the revision procedure, a significant pseudotumor with surrounding tissue damage and necrosis from trunnionosis was debrided.The stem and shell remained intact, and the head and liner were replaced.Medical notes identified patient was revised due to pain, wound complications, shell loosening and radiolucency with apparent acetabular screw fracture.Lucency around acetabular component with rotation, significant lucency is seen along the acetabular screw.Fractured superior right acetabular screw.Lucency around the proximal aspect of the femoral component with bone formation and surrounding soft tissues which could be heterotopic bone formation (unconfirmed).Abnormal appearance of the right hip prosthesis suggesting loosening.Prosthesis in place that appears to be compressing the external iliac vein, massive edema of the leg.Aseptic loosening rule out possible sepsis.Ebl 850ml, prbcs infused.Severe thickened fibrous tissue noted, partial deskeletonization of the proximal femur (eto) necessary to gain access.Acetabulum too excoriated with too many cavities for good fixation of the acetabular component.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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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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