ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD, ø 50-18, R=27.6MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377)
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Event Date 05/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source foreign ¿ switzerland.D10 ¿ anatomical shoulder, humeral stem, uncemented, 14, 100 mm item#0104201143 lot#3014292; anatomical shoulder domelock, dome, centric item#0104227005 lot#2992775; anatomical shoulder, glenoid, pegged, cemented, m item#0104214370 lot#2993482.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00230, 0009613350-2023-00232, 0009613350-2023-00233. 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 that the patient underwent initial bilateral anatomic total shoulder arthroplasties.Post-operative grade iv glenoid radiolucency with osteolysis in zones 1-3, osteophytes, and grade iii heterotopic ossification were diagnosed approximately two (2) years after surgery and decreased strength, range of motion, and satisfaction with mild-moderate pain were reported approximately three (3) years from initial shoulder arthroplasty.Revision surgery is planned.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Initial bilateral anatomic total shoulder arthroplasties were performed.At the two year follow up visit for the right side, grade iv glenoid radiolucency with osteolysis in zones 1-3, osteophytes, and grade iii heterotopic ossification were noted on x-ray.By the three year follow up, the patient reported decreased strength, range of motion, and satisfaction with mild-moderate pain.A revision from an anatomic to reverse is planned.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment crf report was received and reviewed by the nurse review group (hcp), for which a timeline report was created.The following findings were noted during initial implantation: sclerotic bone, large osteophytes, rotator cuff intact, subscap and capsule releases, no intraop complications noted, pressfit stem, cemented glenoid, discharged postop day 5, pt started, mobilized within 24 hours of surgery.Six radiographic images of the right shoulder were provided and assessed by mri (hcp - radiologist) with the following assessment: 2020 - normal alignment of the right glenohumeral arthroplasty 2022 - there is early osteolysis along the glenoid implant and humeral bone-metal interface 2023 - there is marked progression of the proximal humeral osteolysis with more mild progression of the glenoid osteolysis.The following impressions were additionally provided: initial normal appearance of bilateral shoulder arthroplasties with progressive development of advanced bilateral implant osteolysis as noted, greater at the humeral implants.While there is no implant displacement to confirm loosening, the degree of bilateral humeral osteolysis would suggest early loosening.Overall alignment is maintained.Bone quality appears mildly osteopenic.Based on the given information and the results of the investigation, a definitive root cause cannot be determined.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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