Catalog Number 121881756 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2023 |
Event Type
Injury
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Event Description
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Faulty implants replaced with new implants new revision surgery on (b)(6) 2023.Patient had first op on (b)(6) 2023 with a corail (size 12 ho) / pinnacle (sector ii 56mm) with ceramic head (36mm +1.5) and ceramic liner listed above.At some point the superior aspect of the ceramic liner has failed / cracked.The revision surgery involved removing all the ceramic fragments and replacing with a 36mm / 56mm altrx liner and a new 36mm +1.5 ceramic head.Patient didn¿t report any discomfort prior to revision surgery.Doi: (b)(6) 2023.Doe: (b)(6) 2023.
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Manufacturer Narrative
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Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : according to the information received, "patient had first op on 14/04/23 with a corail (size 12 ho) / pinnacle (sector ii 56mm) with ceramic head (36mm +1.5) and ceramic liner listed above.At some point the superior aspect of the ceramic liner has failed / cracked.The revision surgery today involved removing all the ceramic fragments and replacing with a 36mm / 56mm altrx liner and a new 36mm +1.5 ceramic head.Patient didn¿t report any discomfort prior to revision surgery".The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device along with a manufacturing investigation performed by supplier.Visual analysis of the returned sample revealed that the delta cer insert 36id x 56od has fracture into one (1) large, three (3) small and nineteen (19) very small fragments.However, the ceramic liner was not able to be completely reconstructed, there are fragments missing which could potentially yield further information if they were available.Metal transfer of erratic appearance can be found on the outer and inner surface of the large fragment, most likely caused by chafing between metal parts and the broken fragments of the ceramic liner, either after the primary fracture of during the surgical procedures.Additionally, metal transfer patterns around the edge that suggest a symmetrical taper fit between the liner and the acetabular cup cannot be found.The fracture surfaces of the large fragment presents signs of secondary chip-offs since the fragments chafed against each other in the period between the primary fracture event and the delivery of the fragments for investigation.Due to the observed condition of the returned liner and due to missing fragments, the primary fracture surface and the fracture origin cannot be identified.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established.However in support of the evaluation performed, the observed damage of the liner may have been caused by insufficient or misalignment fixation of the liner in the acetabular cup leading to a misaligned position of the liner causing increased local mechanical stress.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.It is worth mentioning that the mating ceramic head was returned for evaluation and no defects or signs of a device non conformance were observed.The femoral head does not provide any indication regarding a possible cause for the failure of the liner.A manufacturing record evaluation was performed for the finished device [121881756 / 3954540] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The density of the liner was analyzed and found to comply with the delivery specification for biolox delta components.The microstructure as obtained from the quality documents meets the requirements specified at the time of production, too.There is no indication of any pre-existing material defect.The overall complaint was confirmed as the observed condition of the delta cer insert 36id x 56od would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the ceramic insert belongs to the shop order 7011700903.Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.The density of the insert was analyzed and found to comply with the delivery specification for biolox delta components.The microstructure as obtained from the quality documents meets the requirements specified at the time of production, too.There is no indication of any pre-existing material defect.Device history review : a manufacturing record evaluation was performed for the finished device [121881756 / 3954540] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.
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Search Alerts/Recalls
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