ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, 32/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD
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Model Number N/A |
Device Problem
Noise, Audible (3273)
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Patient Problems
Loss of Range of Motion (2032); Injury (2348)
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Event Date 05/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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An e-mail requesting additional information was sent to the appropriate representatives.The manufacturer did not receive x-rays, or other source documents for review, neither the device has been received 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.(b)(4).Note: for the shell and liner an additional case is filed: (b)(4).
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Event Description
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It was reported that a patient was implanted with a biolox® delta, ceramic femoral head, s, 32/- 3.5, taper 12/14 on (b)(6) 2016 on unknown hip side.A revision surgery was performed on (b)(6) 2017 because the liner was not engaged in the acetabular shell,therefore the femoral head was now articulating with the acetabular metal shell, resulting for the patient in limited range of motion and squeaking of implant.Note: for the shell and liner an additional case is filed: (b)(4).
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Manufacturer Narrative
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Investigation results were made available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Review of event description: the device was implanted on (b)(6) 2016 and revised on (b)(6) 2017 due to limited range of motion and squeaking.Due to improper fitting of screw, liner was not engaged to the g7 acetabular shell.It had spun inferiorly around the femoral head and the femoral head was now articulating with the acetabular metal shell.The surgeon thought that perhaps a screw was not all the way in and prevented the liner from being fully seated.The surgeon removed both the g7 screws and exchanged g7 liner along with the ceramic head.Review of received data: one picture of the biolox ceramic head was delivered.The biolox ceramic head shows on one side strong singns of wear.The "pink" color on the ceramic head has gone.As reported in the event description the femoral head was articulating with the acetabular metal shell.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Root cause analysis: root cause determination using dfmea: loss of connection due to inappropriate design concerning pull-off strength (head/stem) / pull out strength (head/constrained liner).Not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Increased wear particles from articulation, osteolysis due to inappropriate design concerning tribological performance.Not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Limited range of motion, impingement of components due to inappropriate design concerning range of motion.Not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Increased wear due to foreign particles in cop and coc pairing.Possible: no products were sent back and also no information available about surgery.Noise causes patient dissatisfaction due to implant squeaks or clicks - (stripe wear).Possible: it was reported that the implant squeaks.Implant damage, compromized implant fixation due to impaction force by assembling head on stem taper.Possible: it is possible that the user did a wrong handling during the implantation/assembling.Mal-function of tha (wear, fracture, dislocation etc.) due to wrong size of head diameter and/or offset, wrong taper size combination.Not possible: no issue found with wrong size.Mal-function of tha (wear, fracture, dislocation etc.) due to off label use, combination with competitor products.Not possible: no competitor products used.Loss of connection due to inadequate assembling procedure.Possible: it is possible that the user did a wrong handling during the implantation/assembling.Increased wear, fretting corrosion on stem taper (lever torque) due to patient with high body weight.Possible: no specific patient information was provided.Conclusion summary: the device was implanted on (b)(6) 2016 and revised on (b)(6) 2017 due to limited range of motion and squeaking.During the revision surgery it was discovered that the liner was not engaged in the acetabular shell.It had spun inferiorly around the femoral head and the femoral head was now articulating with the acetabular metal shell.The surgeon thought that perhaps a screw was not all the way in and prevented the liner from being fully seated.The picture provided of the ceramic head shows strong signs of wear.This must have been occurred while the femoral head was articulating with the acetabular metal shell.As no further information like surgical reports or x-rays have been provided, it cannot be determined an exact root cause of the reported event.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).This is a splitcase with zimmer inc.Warsaw reference number: (b)(4).
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