|
Concomitant medical products and therapy date: detail of product: item # 00877503602; item name biolox delta, ceramic femoral head, m, 36/0, taper 12/14; lot # 2738142; item # 00885201436; item name elevated rim liner 36 mm i.D.Size mm for use with 60 mm o.D.Size mm shell; lot # 62727099; item # 00875706002; item name shell with multi holes porous 60 mm o.D.Size m for use with mm liners; lot # 62259789; item # 00625006535; item name bone screw self-tapping 6.5 mm dia.35 mm length; lot # 62754329; item # 00625006525; item name bone screw self-tapping 6.5 mm dia.25 mm length; lot # 62775778; item # 00625006520; item name bone screw self-tapping 6.5 mm dia.20 mm length; lot # 62757370; item # 00625006525; item name bone screw self-tapping 6.5 mm dia.25 mm length; lot # 62822799.The manufacturer received x-rays and other source documents for review.The device has not been received for investigation as the patient has not been revised.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).Product reference unknown.
|
|
Investigation results were made available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: pain and swelling (biolox head).No trigger considering the following event is identified: pain and swelling (wagner sl).Review of event description: it was reported by phone on (b)(6) 2019 that a male patient experiences swelling and pain down the leg since the revision surgery during which antibiotic spacer was replaced with zimmerbiomet implants on (b)(6) 2014.Review of received data: surgical report of implantation, dated (b)(6) 2014: pre-/postoperative diagnosis: left hip antibiotic spacer, status post removal of implants for chronic total hip infection.Procedure performed: left hip removal of antibiotic spacer and left hip revision.Indication for procedure: the patient is a 63-year old male, who is status post left hip removal of implants and antibiotic spacer placement for chronic total hip infection.Description of procedure: the hip was aspirated and clear fluid was sent for a cell count.This showed no signs of acute inflammation.Tissue from the surrounding hip was sent for frozen section and this confirmed no acute inflammation.The antibiotic spacer was removed without difficulty.The bone was carefully reamed to protect the limited remaining bone stock and to prepare a good bed of bleeding cancellous bone.A 60 mm continuum multip hole cup was placed.A good press-fit was obtained.Screws were placed in the posterior-superior quadrant with good purchase.A high wall liner was fully seated.It was decided to use a tapered fluted revision type stem to control the height offset inversion of the implants.The patient did have some deficiency of the calcar bone.The canal was cleared using crochet hooks.The canal was reamed with the reamers up to size 18 reamer.The final 18 x 190 mm sl wagner was placed approx.20-30 degrees of anteversion, which provided maximum stability.A 36+0 mm ceramic head was impacted on the clean dry trunion.Reposition showed good stability.There was 2 mm of shuck.The hip was again copiously irrigated with pulse lavage.Product stickers of the four self-tapping bone screws, the continuum trilogy pe liner, the continuum trabecular metal shell and the cermaic femoral head with reference and lot numbers were provided.The physical therapy instructions for home exercise as well as the visiting dates have been received.The aftercare program is inconspicuous.Discharge instructions are inconspicuous.- patient care summary for m.M., dated (b)(6) 2018: reason for visit: low back pain and left leg pain.Assessment and plan: - radiography of lumbosacral spine taken - patient has chronic lumbar radiculopathy pain with left buttock and posterior thigh, radiating to the calf.Some mild chronic left anterior thigh pain.Patient receives morphine and roxicodone medications and had a lumbar epidural steriod injection approx.In (b)(6) 2017.Patient was already treated with spinal cord stimulator which was removed in 2012 prior to lumbar fusion l3 through sacrum.Additionally, low back pain, total hip replacement, trochanteric bursitis, arthodesis, degeneration of intervertable disc and lumbar spondylosis.Patient care summary for m.M., dated (b)(6) 2018: reason for visit: follow up left tha revision (b)(6) 2014.Assessment and plan: - radiographs show well-fixed implants with no lysis, loosening or wear.- patient had a left hip two-stage reimplanation for infection 2014.Patient has had trochanteric bursitis and iliopsoas tendinitis in the past.He has received trochanteric injections.Patient was doing well until approx.(b)(6) 2018 when he began having discomfort not related to an injury.He has chronic back pain which was treated with a lumbar fusion.His exam is consistent with trochanteric bursitis and iliopsoas tendinitis, he was given a cortisone injection for the bursitis.Patient care summary for m.M., dated (b)(6) 2017: reason for visit: follow up left tha revision (b)(6) 2014.Assessment and plan: - radiography of hip and pelvis with no observation recorded - problems with trochanteric bursitis and psoas tendinitis patient care summary for m.M., dated (b)(6) 2016: reason for visit: follow up left tha revision (b)(6) 2014.Assessment and plan: - radiography of pelvis with no observation recorded - problems with trochanteric bursitis and psoas tendinitis, patient received left hip iliopsoas tendon injection.- radiology report lumbar spine lateral with flexion and extension view (b)(6) 2019: fusion from l3 to s1 with bilateral screws and vertical connecting rods.Hardware looks intact.No evidence of fracture.There is vertebral body spurring.No abnormal motion.- radiology report ap pelvis and left frog leg lateral hip view (b)(6) 2019: there is a left hip prosthesis which is normally situated.Fusion of the lower lumbar spine and sacrum.No evidence of fracture.Normal right hip.No acute findings of left hip.- radiology report nm bone scan flow (b)(6) 2018: indication: loosening of left hip 2014 arthroplasty, left hip pain impression: posterior left hip soft tissue inflammation.Arthroplasty loosening is not defined.- radiology report of mr lt hip wo contrast (b)(6) 2018: indication: left hip pain impression: 1.Left hip prosthesis, which limits evaluation due to adjacent artifact.2.Approximately 6.6 x 1.5 x 1.6 cm sized fluid collection is seen adjacent to the left greater trochanter, may represent bursitis.3.Increased signal is seen around the femoral component of the prosthesis, artifactual or on the basis of fluid/edema.Please consider orthopedic consultation.- test details, sample collected (b)(6) 2019: nickel, serum <2.0 g/l ok cadium, blood <1.0 g/l ok chromium, blood <0.4 g/l ok protein electropheresis all values ok monoclonal protein, blood serum all values ok sed rate 5 mm/hr ok c-reactive protein 0.Mg/dl ok devices analysis: no product was returned to zimmer biomet for in-depth analysis, as the products remain implanted.Review of product documentation: - all involved devices are intended for treatment - the compatibility check was performed and showed that the product combination was approved by zimmer biomet.-the sterilization certificate of the biolox delta head showed that the sterilization was performed according to specification.- the ifu and the surgical technique of the biolox head were pulled, the documents for the wagner stem could not be pulled as the lot number is unknown.Comparison of the surgical report and the surgical technique of the biolox head was inconspicuous.- recall check: there has not been any recall for biolox head ref: (b)(4), lot: 2738142.There has not been any recall for wagner sl stem ref: (b)(4).Conclusion summary: after a two-stage revision surgery due to infection of a previously implanted hip arthroplasty on (b)(6) 2014 the patient experiences swelling and pain down the left leg.Previously, patient was treated with spinal cord stimulator which was removed in 2012 prior to lumbar fusion l3 through sacrum.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent a left hip revision procedure on (b)(6) 2014.The antibiotic spacers were removed and real implants were implanted.A zimmer biomet continuum cup 60mm, sl wagner stem, vitamin e high wall poly liner, and a biolox ceramic head 36mm + 0 were used to complete the procedure.Desired fit and range were achieved.The patient tolerated the procedure well.On (b)(6) 2018, the patient visited the surgeon due to pain with left buttock and posterior thigh, radiating to the calf.The patient also had some mild chronic left anterior thigh pain.Mri exam dated (b)(6) 2018 identified fluid collection adjacent in left greater trochanter, possibly representing bursitis.A bone scan dated (b)(6) 2018 identified soft tissue inflammation in the posterior left hip.The laboratory results dated (b)(6) 2019 did not show any abnormal values.Further, no reported observations were stated in regards to the left hip implants in any of the radiography reports.The medical condition of the patient prior to revision performed (b)(6) 2014 is unknown.The quality records of the biolox head show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Therefore, the investigation results of the biolox delta head did not identify a non-conformance or a complaint out of box (coob).The quality records of the wagner sl stem could not be reviewed as the lot number is unknown.No recall was performed for the biolox head (ref: (b)(4), lot: 2738142) and no recall was performed on any wagner sl product batch.Based on the investigation no specific root cause could be identified for the reported issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
|
