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Concomitant medical products - medical products and therapy date: detail of product: item # 0104213520, item name a.S.Humeral head d 52 h 23, lot # 2179577; item # 0104227102, item name a.S.Ball-taper for hum stems, lot # 2339477; item # 0104201142, item name a.S.Humeral stem 14, lot # 2273051.This event was previously reported by (b)(4) site under the reference 0001825034-2019-00481, but following the identification of (b)(4) as manufacturer the case was assigned to zimmer biomet (b)(4).The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.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).
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This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: loosening.Event description: it was reported that the patient underwent a right shoulder arthroplasty on (b)(6) 2006.After approx.9 years in-vivo the patient was experiencing progressive pain in the right shoulder with limited rom.On (b)(6) 2015 the patient was revised due to prosthesis loosening.Review of received data: no x-rays were received for review.Hospital discharge letter and surgical report of primary implantation from st.Josef-hospital in troisdorf were received for review: hospital discharge letter (b)(6) 2019: therapy: implantation of a shoulder total endoprosthesis anatomical (cemented glenoid coarse m, humeral head 52/53, cementless stem coarse 14) on (b)(6) 2006 (note: in the surgical report the day of surgery is stated as (b)(6) 2019.Anamnesis: a fall event on the right shoulder in adolescence.Ever since constant shoulder pain.Intensive conservative treatment showed no signs of improvement.Course: the postoperative course was unremarkable with irritation-free wounds.At the time of discharge the shoulder was well ebb away.The patient has a little pain only.Surgical report (b)(6) 2006: anterior-deltopectoralis access.The rotator cuff is intact.Opening of the glenohumeral joint.Advanced omarthrosis present.Distinct collar osteophytes.Luxation of the humeral head.Removal of the cartilage.Preparation of the glenoid and the humerus.Insertion of the trial components.Trial reposition.Perfect fit without luxation tendency with a good range of motion.Cemented implantation of the glenoid implant size m.After cement setting implantation of a cementless humeral stem size 14 with a humeral head size 52/23.Again perfect fit.No luxation tendency with a good range of motion.Surgical report of revision, klinikum worms (b)(6) 2015: diagnosis: loosening of right shoulder prosthesis therapy: explantation endoprosthesis shoulder left (note: should be right, there is no comment about a procedure on the left side within the surgical report), implantation of an inverse total endoprosthesis shoulder right.Course: the patient presented at the consulation visit.The patient was having severe pain in the right shoulder joint when mobilizing.The pain had been progressive for months.About 10 years earlier, anatomical shoulder joint prosthesis type anatomical of the fa zimmer had been implanted in pre-existing osteoarthrosis.The clinical and radiological diagnostics revealed a painful subacromial impingement in combination with a cuff tear arthropathy and a pronounced prosthetic head elevation, as well as movement pain.Procedure: incision of pre-existing skin scar.Scarred tissue is located on the humeral head.A very weak subscapularis tendon is present in which still suture material is present, which is removed.Form the joint clear synovial fluid empties.In addition, there is a clear irritant synovitis, from which samples are obtained for microbiological and histological examination.The dorsal parts of the supraspinatus tendon no longer exist except for a narrow ventral web and also the infraspinatus tendon no longer exists, so that these residual tissue fibers are now cut to dislocate the humeral head.Next, the anatomical prosthetic head is easily removed from the cone.The bone overall impressed with virtually no signs of infection.The prosthesis stem is highly stable.The soft tissue around the glenoid is removed anteriorly and inferiorly, by doing so the polyethylene onlay detaches completely from the underlying glenoid bone.Therefore, the reason for the patient's complaints, is a loosening of the polyethylene component.Strikingly, after removal of the onlay, only small amounts of cement had been introduced in the area of the 4 mortise holes.The back surface of the polyethylene onlay had very little cement material.Consequently, implantation of an inverse glenoid, fixed with two angle stable screws, without difficulties.Further, a neutral humeral head with 6 mm inlay is mounted on the well fixed humeral stem.Finally, exact fit between glenoid and humeral components with good range of motion, no luxation tenency.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.The product combination was approved by zimmer biomet.Surgical technique: cementing, page 9: the glenoid surface and the anchoring holes are now carefully cleaned and dried.The anchoring holes are filled with bone cement and the cement is pressed into the anchoring holes with a clean compress or using the corresponding instruments.Glenoid cement setting instrument for pegged glenoid can be used for all three sizes s, m and l.The anchoring holes are then filled where necessary and cement is applied to the glenoid surface and the back side of the implant.The implant is then cemented into place using the glenoid impactor.Note: do not use the impactor on the implant while the cement is hardening.The excess cement is immediately and carefully removed with a knife blade.Root cause analysis: root cause determination using sap rmw: mechanical loosening due to cemented fixation of the poly glenoid destabilises, leading to loosening of the prosthesis from the glenoid bone possible, as during the revision surgery only little cement material was found which loosened from the glenoid bone.Inadequate range of motion, or glenoid loosening due to provided scope of implants does not meet anatomical requirements.Possible, as this cause cannot be excluded due to unavailability of x-rays, nevertheless, in the surgical report implant positioning was stated to be good.Aseptic loosening due to laser marking/engraving not readable in normal lighting conditions leads to use of wrong implant not possible, as neither in the primary nor in the revision report indication is given that the wrong size was implanted.Further, the labels were reviewed and conform with the sizes described in the surgical report.Surgery failure (e.G.Aseptic loosening, fracture of implant, fracture of bone, wrong soft tissue balancing, etc.) due to insufficient or overly complicated surgical technique not possible, as no indication is given that unclear or complicated information was an issue during primary implantation.Poor surgical outcome, pain, insufficient function etc due to surgeon does not follow the surgical technique possible, as the surgical report of the revision surgery describes insufficient amount of cement material on the glenoid surface and within the anchoring holes of the glenoid component.Surgery failure (e.G.Aseptic loosening, fracture of implant, fracture of bone, wrong soft tissue balancing, etc.) due to missing or unclear information regarding cross compatibility between existing zimmer biomet systems and sizes not possible, as the compatibility check showed that the implanted component combination was approved by zimmer biomet.Conclusion: it was reported that the patient underwent a right shoulder arthroplasty on (b)(6) 2006 due to a fall event on the right shoulder in adolescence.After approx.9 years in-vivo the patient was experiencing progressive pain in the right shoulder with limited rom.On (b)(6) 2015 the patient was revised from the anatomical shoulder system to an inverse shoulder system due to prosthesis loosening.In the surgical report of the revision surgery which took place on (b)(6) 2015 a very weak subscapularis tendon was found.In addition, also the dorsal parts of the supraspinatus tendon and the infraspinatus tendon were almost inexistent.The bone overall impressed with virtually no signs of infection and also the synovial fluid presented very clear.The polyethylene onlay was found to be completely loose and hardly any cement material was found underneath the onlay on the glenoid bone and inside the 4 peg holes.Within the surgical technique instructions for the glenoid cementing are given.The cement must be filled and pressed into the anchoring holes and onto the glenoid surface in order to provide sufficient fixation.The quality records of the glenoid, the humeral head and the ball-taper for the stem were reviewed and showed that all specified characteristics have met the specifications valid at the time of production.Based on the surgical report of the revision surgery, it can be assumed that the highly weakended, almost inexistent, muscles of the rotator cuff caused the reduced function of the right shoulder, a prosthetic head elevation, the described impingement and pain.In addition, based on the received medical documentation and the investigation the inappropriate cementing of the glenoid component was found to be the most likely root cause for the glenoid loosening, leading to revision of the system after approx.9 years in-vivo.Also the humeral head and the taper ball were revised, however, no product issue was identified for these products, as these products had to be revised together with the glenoid component in order to revise the anatomical shoulder to an inverse shoulder system.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).
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