ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD, 48, CODE N, TAPER 18/20; HIP PROSTHESIS
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Model Number N/A |
Device Problems
Biocompatibility (2886); Appropriate Term/Code Not Available (3191)
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Patient Problems
Foreign Body Reaction (1868); Local Reaction (2035); Osteolysis (2377)
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Event Date 03/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Medical products: zimmer mmc, cup, uncemented, 56 mm/48 mm, code n; catalog#: 01.00634.056; lot#: 2528553; metasul ldha, head adapter, m, 0, taper 12/14-18/20; catalog#: 01.00185.146; lot#: 2585758; fitmore, hip stem, uncemented, b/7, taper 12/14; catalog#: 01.00551.207; lot#: 2538809.Therapy date: (b)(6) 2021.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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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Event Description
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Patient was implanted on an unknown side and underwent a revision surgery due to massive acetabular osteolysis, metallosis (trunionosis) and elevated metal ions in blood.The stem was retained during the revision surgery and other components have been explanted.
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Manufacturer Narrative
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Additional information which was received on apr 07, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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Event Description
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Patient was implanted on an unknown side and underwent a revision surgery due to massive acetabular osteolysis, metallosis (trunionosis) and elevated metal ions in blood.The stem was retained during the revision surgery and other components have been explanted.
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Event Description
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Investigation results were made available.
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Manufacturer Narrative
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Investigation results were made available.Additional: h2, h6.Correction: b4, b5, d6, d9, g3, g6, h3, h10.1.Event description: it was reported that the patient was implanted with a thp on (b)(6) 2011.The asymptomatic patient underwent revision surgery on (b)(6) 2021 due to acetabular osteolysis, metallosis (trunionosis) and elevated metal ions in blood.The fitmore stem was left in-vivo during revision surgery.Harm: s3 - osteolysis leading to revision.Hazardous situation: fragments of an implant and/or bone are generated in vivo.2.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Medical images: summary of imaging, 6 images were received: 1 - coronal ct reformatted image.2 - reformatted ct image 3 - oblique view left hip 4 - ap pelvis (b)(6) 2019 5 - oblique view left hip dated (b)(6) 2011 6 - ap pelvis (b)(6) 2011 the following assessment of the images was performed by a radiologist.Early images of (b)(6) 2011 demonstrate anatomic alignment of the left hip arthroplasty (inclination angle approx.50°).Later radiographs and reformatted ct images demonstrate development of acetabular osteolysis superiorly.No loosening is identified.Bone quality appears normal.-additional medical records were not provided due to patient privacy policy.3.Product evaluation: -visual examination: the mmc cup and the large diameter head were returned for examination.Around one-quarter of the anchoring surface of the mmc cup is covered with bone remnants.The ldh shows scratches on the articulation surface.Further, at the head taper an imprint is visible close to the bottom.4.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no relevant deviations or anomalies during manufacturing.5.Conclusion: it was reported that the patient was implanted with a thp on (b)(6) 2011.The asymptomatic patient underwent revision surgery on (b)(6) 2021 due to acetabular osteolysis, metallosis (trunionosis) and elevated metal ions in blood.The fitmore stem was left in-vivo during revision surgery.Based on the medical images provided, the development of acetabular osteolysis can be confirmed.The visual examination shows bone remnants covering around one-quarter of the shell's anchoring surface.The ldh adapter and the stem (which was left implanted) were not returned; therefore, the reported trunnionosis cannot be verified.Medical records demonstrating high metal ion levels, metallosis, or trunionnosis were not provided.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information a definite root cause cannot be identified.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
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