ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 46 MM/38 MM, CODE D; ZIMMER MMC CUP
|
Back to Search Results |
|
Model Number N/A |
Device Problems
Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Metal Related Pathology (4530)
|
Event Date 10/14/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: metasul ldh, head, 38, code d, taper 18/20; catalog#: 01.00181.380; lot#: 2282596.Metasul ldh, head adapter, m, 0, taper 12/14-18/20; catalog#: 01.00185.146; lot#: 2514228.Therapy date: (b)(6) 2020.The manufacturer received x-rays and 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.(b)(4).
|
|
Event Description
|
Patient was implanted on an unknown side and underwent revision surgery due to armd(metallosis).During the revision surgery part of the coating detached from the cup when removing it and rest of the coating had to be removed with a chisel from the bone.
|
|
Manufacturer Narrative
|
Additional information which was received on nov 4, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received 3 x-rays with printed date, revision report and implantation report 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).
|
|
Event Description
|
Patient was implanted on an unknown side and underwent revision surgery due to armd(metallosis).During the revision surgery part of the coating detached from the cup when removing it and rest of the coating had to be removed with a chisel from the bone.
|
|
Event Description
|
Investigation has been completed.
|
|
Manufacturer Narrative
|
Investigation results were made available.Event description: it was reported that the patient was implanted with mmc cup and ml-taper stem on (b)(6) 2010.Patient underwent revision surgery on (b)(6) 2020 due to armd.Part of the coating detached from the cup when removing the cup and rest of the coating had to removed with a chisel from the bone.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.X-rays: 4 x-rays were received that were taken after the revision surgery and are therefore not included in the investigation.Images: no pictures were taken during the surgery.Lab results: year 2020 chrome 6,9 mikrogramm/liter; cobalt 12 mikrogramm/liter.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: select product compatibility.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient was implanted with mmc cup and ml-taper stem on (b)(6) 2010.Patient underwent revision surgery on (b)(6) 2020 due to armd.Part of the coating detached from the cup when removing the cup and rest of the coating had to removed with a chisel from the bone.Neither operative notes, official lab results, nor device(s) or photos of the device(s) were received; therefore the condition of the component is unknown.Further, lab results from 2020 were reported with no official lab report.It remains unknown when exactly and with what medium they were taken.Therefore, an evaluation only based on the values is not possible.Based on the investigation the reported event cannot 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 can only assume that the cup was well integrated into the bone which led to the detachment of the coating during the revision surgery.However, based on the investigation we were not able to identify a specific root cause for the reported armd which led to the revision surgery.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).
|
|
Search Alerts/Recalls
|
|
|