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
Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Failure of Implant (1924); Pain (1994); Depression (2361); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 10/14/2020 |
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 product: zimmer mmc, cup, uncemented, 56 mm/48 mm, code n; item# : 0100634056; lot# : 2564524.Metasul ldh, head adapter, s, -4, taper 12/14-18/20; item# : 0100185145; lot# : 2565568.Femoral stem beaded fullcoat 12/14 neck taper std.Body std.Offset size 11 11 mm distal dia.160 mm length; item# : 00784301106; lot# : 61710257.Therapy date: (b)(6) 2020.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.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 right side and underwent revision surgery due to pain, swelling, elevated metal ion levels and osteolysis.During the revision surgery the following were reported: large metallosis fluid collection in the deep subcutaneous tissue that dissected through the distal it band.Underlying pseudotumor - just distal to the gluteal sling.Focal pseudotumor just distal to the gluteal sling that dissected out in its entirety.Moderate trunionosis around the base of the trunnion.The trunnion itself was intact with no signs of gross damage.After removing the acetabular component, there was significant metallosis within the acetabulum and cavitary osteolytic defects.
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Event Description
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No change to previously reported event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient underwent an initial right hip resurfacing on (b)(6) 2012 which was converted into a right tha due to femoral neck fracture on (b)(6) 2012.The patient showed no symptoms after this until he presented with pain, swelling, elevated metal ion levels and osteolysis and hence underwent a second revision surgery on (b)(6) 2020.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.- mri report: review of the received report identified small fluid collections; however, no definitive diagnosis could be determined.- surgical report: review of the received report by a health care professional identified that the patient experienced pain, swelling, elevated metal ions, and osteolysis around the acetabular and femoral components.Signs of metallosis were detected in the subcutaneous tissue though the distal it band and within the acetabulum and cavitary osteolytic defects.There was an underlying pseudotumor by the distal it band.The base of the trunnion had moderate trunnionosis.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.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 the following deviations and/or anomalies: ncr 200149350.- ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient underwent an initial right hip resurfacing on (b)(6) 2012 which was converted into a right tha due to femoral neck fracture on (b)(6) 2012.The patient showed no symptoms after this until he presented with pain, swelling, elevated metal ion levels and osteolysis and hence underwent a second revision surgery on (b)(6) 2020.Based on the investigation the reported event can be confirmed.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 and the results of the investigation, we were not able to identify a specific root cause for this issue.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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information on the reported event.
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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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No products were returned; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a right hip resurfacing procedure and was converted to a total hip.Zimmer biomet components were implanted without complications.The patient underwent a revision procedure due to failed hip arthroplasty.The patient presented with pain and swelling.Metal ions in the blood were elevated and there was osteolysis around the acetabular and femoral implants.There was a large metallosis fluid collection in the deep subq tissue through the distal it band with underlying pseudotumor.Moderate trunnionosis was noted at the base of the trunnion.The cup, liner, and head were replaced with competitor's products.No other finding/complication related to the reported event was noted.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2021-00267, 0009613350-2021-00263.
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