MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA FEM STEM BOLT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960770
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.
Event or Problem Description
Radiographs of a patient who underwent revision tkr 3 years back.At present she presented a failed implant with a bolt and stem junction.Its seems to be broken.
Additional Manufacturer Narrative
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 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.
Event or Problem Description
Additional information received states that the patient had difficulty in walking and felt severe pain in the affected area.When screening was done at the hospital, the bolt and stem was found to be broken.Post screening, broken implants were removed on (b)(6) 2024 during which the patient was found to have severe bone loss due to metallosis.Because of bone loss, distal femur lps re-revision was done on (b)(6) 2024.
Additional Manufacturer Narrative
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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
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 reconstruction, or its employees caused or contributed to the potential event described in this report.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
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: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: radiographs of a patient who underwent revision tkr 3 years back.At present she presented a failed implant with a bolt and stem junction.Its seems to be broken.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.Photo/x-ray investigation revealed the distal portion of the pfc sigma fem stem bolt fractured.The mode of failure of the device is multi-factorial and consideration must be given to all other 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.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pfc sigma fem stem bolt would have contributed 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 j&j medtech orthopaedics 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: a manufacturing records evaluation (mre) was not performed as no valid lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: radiographs of a patient who underwent revision tkr 3 years back.At present she presented a failed implant with a bolt and stem junction.Its seems to be broken.The product was returned to j&j medtech orthopaedics for evaluation and was examined through stereomicroscopy and scanning electron microscopy by the r&d and testing team.Visual inspection revealed the pfc sigma fem stem bolt had fractured at its proximal most thread root, where two fracture initiation sites were identified.Broken fragment was found inside of the pfcsig cem fem stem5dg13x130mm.The fracture of the bolt is consistent with low-stress high-cycle fatigue.Furthermore, the fracture surface had two initiations, where the fatigue crack from one initiation made up the majority of the fracture surface.Fracture or damage to other components of the device (including femoral stem, capture ring, adaptor/spacer, and cam post) was determined to be secondary to the bolt fracture itself and likely due to overloading.There was no evidence of inclusions or other defects on the bolt that could have contributed to crack initiation or propagation.However, with information provided, a definitive cause cannot be established for the fracture itself and consideration must be given to all other 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.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the pfc sigma fem stem bolt would have contributed 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 j&j medtech orthopaedics 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: a manufacturing records evaluation (mre) was not performed as no lot number was able to be retrieved for this device.If the lot/serial number becomes available, the record will be re-assessed.H11 additional narrative: corrected: h3.

• Brand Name: PFC SIGMA FEM STEM BOLT
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19989897
• Report Number: 1818910-2024-17438
• Device Sequence Number: 8585882
• Product Code: JWH
• UDI-Device Identifier: 10603295233893
• UDI-Public: (01)10603295233893
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 960770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 08/20/2024; 10/07/2024; 03/12/2025; 03/21/2025; 05/19/2025
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 08/28/2024; 09/02/2024; 10/08/2024; 03/13/2025; 03/24/2025; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFCSIG CEM FEM STEM5DG13X130MM; UNK KNEE FEMORAL SIGMA; UNK KNEE STEM; UNK KNEE TIBIAL INSERT SIGMA; UNK KNEE TIBIAL TRAY SIGMA; UNKNOWN KNEE TIBIAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown