| Catalog Number |
960090 |
| Medical Device Problem Code |
Loss of or Failure to Bond (1068)
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| Health Effect - Clinical Codes |
Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Muscular Rigidity (1968); Pain (1994); Joint Laxity (4526)
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| Date of Event |
01/16/2026
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Type of Reportable Event
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Serious Injury
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Additional 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 medwatch, a follow-up medwatch will be filed as appropriate.D4: udi: as the catalog/model number was not provided, the (01) gtin is not available.
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Event or Problem Description
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It was reported on (b)(6) 2016, the patient received a depuy revision knee system implant in the right knee.The components included a sigma 5 femoral size 1 and a metaphyseal sleeve size 4, tc3 type.In (b)(6) 2025, x-rays revealed loosening of the tc3 component and broken screws.On (b)(6) 2026, the patient underwent a knee revision surgery due to the premature failure of the depuy sigma tc3 component.Relief is sought for pain and suffering resulting from the device failure, the latent defect, and the subsequent need for revision surgery.Doi: (b)(6) 2016.Dor: (b)(6) 2026.Affected side: right knee.
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Additional 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 that 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 recon described in this report.Added: a2, a3a, h6 health effect clinical code.Corrected: b7.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
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Additional Manufacturer Narrative
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Product complaint: (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the 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.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.Added: b5, b7, d10 (concomitant).
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Event or Problem Description
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Additional information received: updated: medical record ad (b)(6) 2026 have been review by a clinician: on (b)(6) 2016: male patient received a right knee revision of an unk tka to treat stiffness, arthrofibrosis, and pain.The patient received a depuy tc3 including a femoral sleeve, femoral adaptor and bolt, hinged femoral component, hinged tibial insert, mbt tibial tray, tibial sleeve, and tibial stem.The unknown patella was retained.Unk cement was utilized.The procedure was completed without complications.On (b)(6) 2016 the male patient received an mua, synovasure aspiration, and intraarticular injection to treat pain, swelling, stiffness, and arthrofibrosis s/p tc3 implantation.No infection was detected and rom restored to normal limits.This is a new event to be captured on a linked, separate complaint.Doi: (b)(6) 2016.Doe: (b)(6) 2016.Right knee.
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Additional Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, "on (b)(6), 2016, the patient received a depuy revision knee system implant in the right knee.The components included a sigma 5 femoral size 1 and a metaphyseal sleeve size 4, tc3 type.In (b)(6) 2025, x-rays revealed loosening of the tc3 component and broken screws.On (b)(6) 2026, the patient underwent a knee revision surgery due to the premature failure of the depuy sigma tc3 component.Relief is sought for pain and suffering resulting from the device failure, the latent defect, and the subsequent need for revision surgery.Doi: (b)(6) 2016.Dor: (b)(6) 2026.Affected side: right knee."
product description:- pfc*sigma tc3 fem rt sz5.Product code:- 960090.Lot no:- c46301.Quantity of manufactured:- (b)(4).Date of manufacturing:- 20-jun-2016.Expiry date:- 31-may-2026.Ifu reference :- 090200252.A manufacturing record evaluation was performed for the finished device product description: pfc*sigma tc3 fem rt sz5, product code: 960090, lot number: c46301 and no non-conformances / manufacturing irregularities were identified.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.If additional information is made available, the investigation will be updated as applicable.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 20-jun-2016.3) any anomalies or deviations identified in dhr: no non-conformances / manufacturing irregularities were identified.4) expiry date: 31-may-2026.5) ifu reference: 090200252.Device history review: a manufacturing record evaluation was performed for the finished device product description: pfc*sigma tc3 fem rt sz5, product code: 960090, lot number: c46301 and no non-conformances / manufacturing irregularities were identified.
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Additional 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.
h11 additional narrative:
added: d4 (catalog, lot, expiration date, primary udi number), d10 concomitant, h4.Corrected: d1, d2a.
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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Additional 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.H11 additional narrative:
corrected: d6b.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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Search Alerts/Recalls
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