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Reported event: an event regarding altr and audible noise involving an unknown liner was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a male patient who underwent a primary cementless ceramic on ceramic total hip arthroplasty.I can confirm that the patient underwent this procedure since i was able to see postoperative x-rays.The patient subsequently developed squeaking of the hip with sensory numbness and underwent revision where a pseudo-tumor was found that was compressing the femoral nerve.A decompression was carried out as well as revision of the acetabular liner and femoral head.The only confirmation i have of the revision surgery is the narrative.I have no operation report, office notes or post revision x-rays.Therefore i cannot confirm the revision with certainty.The root cause of squeaking and pseudo-tumor with compression of the femoral nerve cannot be determined with certainty.The causes are multifactorial including surgical technique factors, patient factors including activity level and bmi, as well as implant factors.Review of the case report in the article supplied showed no evidence of any prosthetic dysfunction and no corrosion surrounding the acetabulum liner or the femoral head.Given those findings, i cannot assign a direct causality to the implant itself." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to squeaking and adverse local tissue reaction.Intraoperatively, stripe wear was observed on the ceramic head.A review of the provided medical information by a clinical consultant indicated: "this inquiry concerns a male patient who underwent a primary cementless ceramic on ceramic total hip arthroplasty.I can confirm that the patient underwent this procedure since i was able to see postoperative x-rays.The patient subsequently developed squeaking of the hip with sensory numbness and underwent revision where a pseudo-tumor was found that was compressing the femoral nerve.A decompression was carried out as well as revision of the acetabular liner and femoral head.The only confirmation i have of the revision surgery is the narrative.I have no operation report, office notes or post revision x-rays.Therefore i cannot confirm the revision with certainty.The root cause of squeaking and pseudo-tumor with compression of the femoral nerve cannot be determined with certainty.The causes are multifactorial including surgical technique factors, patient factors including activity level and bmi, as well as implant factors.Review of the case report in the article supplied showed no evidence of any prosthetic dysfunction and no corrosion surrounding the acetabulum liner or the femoral head.Given those findings, i cannot assign a direct causality to the implant itself." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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It was reported that the patient's left hip was revised due to squeaking.Intra-operatively, pseudotumor was noted.The alumina head and liner were revised, the shell and accolade tmzf stem were not.Rep confirmed that no further information will be released by the hospital or surgeon.Update 25/january/2024 wg: as reported in abstract "femoral nerve compression due to adverse local tissue reaction after ceramic-on-ceramic total hip arthroplasty (arthroplasty today 19 (2023) 101035): "in july 2020, a 71-year-old male presented with left hip pain 13 years after a posterior-approach left tha.The patient¿s medical history was significant for hyperlipidemia and deep vein thrombosis with pulmonary embolism for which he is on atorvastatin and rivaroxaban, respectively.The patient received a stryker trident titanium acetabular shell with a titanium backed third-generation trident 0° alumina insert ceramic liner and a 32-mm alumina taper ceramic head.A stryker accolade tmzf was used for the femoral component.The patient¿s 6-week history of pain and simultaneous ¿squeaking¿ started after he flexed at the hip to retrieve a ball while playing pickleball.He also had associated sensory numbness in the anterior and anteromedial thigh with no history of trauma or falls.At presentation, he characterized his pain as sharp, intermittent, and nonradiating and rated it a 5/10 on the visual analog scale.His symptoms were alleviated with rest, while his numbness, fullness at the hip, and ¿squeaking¿ remained.He denied fever, chills, or recent or remote infections.Physical examination revealed full extension with 80° of flexion, 10° of internal rotation, 30° of external rotation, 30° of abduction, and 10° of adduction.The patient had a clinically stable left hip.He ambulated with a normal tandem gait without the use of an assistive device.His posterolateral hip incision was well-healed, and there was no palpable mass or swelling.He had pain with log roll and resisted hip flexion, and flexion, abduction and external rotation and flexion, adduction, internal rotation tests were also positive.He had diminished sensation over the anterior aspect of the left thigh, but all other distributions were intact.The rest of the patient¿s physical exam including a thorough spine examination was within normal limits.Radiographs of the left hip and anterior-posterior pelvis demonstrated a well-fixed press-fit tha with a single-wedge taper femoral component consisting of a ceramic head articulating with a metal backed ceramic acetabular liner.Using.Hip navigation system templating software, the acetabular inclination was found to be 33°, and the anteversion was 17°.The patient¿s magnetic resonance images revealed a heterogenous mass along the anterior aspect of the hip from the psoas muscle up through the iliacus measuring 7 x 5 x 5 cm, which also extended into the pelvis.Blood tests revealed a normal differential with a white blood cell count of 6.5 billion cells/mcl, and the sedimentation rate (9 mm/h) and c-reactive protein (1 mg/l) level were also within normal limits.Cobalt was not detected (0.0-0.9 ug/l), the chromium level was 0.6 ug/l (0.1-2.1 ug/l), and titanium levels <10.0 mg/ml (<10.0 mg/ml) were obtained, which were found to be within normal limits [6,7].The diagnosis of failed left hip arthroplasty and compressive neuropathy of the left femoral nerve due to an altr was discussed with the patient, and the patient elected to undergo a revision of his left tha.An anterior approach was utilized as it was thought to provide the best opportunity to simultaneously revise the hip and decompress the mass while reducing the risk of posterior instability given the measured acetabular anteversion.Intraoperatively, an 8-cm anterior hip incision was made and carried obliquely toward the fibular head.An anterior capsulotomy was performed, and normal appearing synovial fluid was encountered and sent for culture.We encountered some granulomatous tissue at the inferior capsule, but no discrete mass was identified.The anterior capsulotomy was carried out proximally, which revealed a large granulomatous mass that was excised off the pelvic brim and sent for permanent pathology evaluation and aerobic, anaerobic, fungal, and mycobacterial cultures.The blunt dissection was directed medially, while palpating for the femoral pulse, which expressed copious amounts of brown granular tissue.An in situ dislocation of the ceramic head from the stem¿s taper was performed.Upon inspection, the ceramic head showed evidence of stripe wear.A curved osteotome and mallet were used to atraumatically remove the titanium-backed ceramic liner, which had no evidence of backside wear on the titanium insert.The cup was found to be well-fixed, and the trunnion appeared intact and without corrosion.We debrided around the stem-femur interface to better evaluate the stem fixation and attempted to extract the femoral stem which was solidly fixed.There was no evidence of impingement of the stem from the raised acetabular liner, thus the femoral component was left in place.A 36 +3-mm head was tried, which was found to be stable.The final prosthesis was placed, utilizing a ceramic head, a polyethylene liner, and a titanium sleeve over the femoral neck.We applied a 10° lipped polyethylene liner posteriorly as the acetabular shell appeared to be inadequately anteverted.The hip was reduced and found to be stable in all planes.A histologic analysis for the specimen demonstrated a fibrinous exudate intermixed with few macrophages and blood.Scattered foreign-body-type multinucleated giant cells were also found, and no synovial or periarticular soft tissue was identified.".
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