MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM LEFT S2.5; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0086
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); No Code Available (3191); Physical Asymmetry (4573); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).(b)(4).
Event or Problem Description
Patient communication received.As verbalized,"i have a depuy tc knee revision system- pfc sigma knee replacement.I have limited range of motion, the pain goes down to the femur part of the leg down to my ankle.I'm having problems of this apart from being not stable." update 23-may-2018: patient confirmed the above symptoms of pain, swelling, and decreased rom.Medical records report pain, and indicate that patient has had a knee revision on an unknown date.Doi: (b)(6) 2013.Dor: unknown (left knee).
Additional Manufacturer Narrative
If the information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: update (b)(6) 2020: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.H10 additional narrative: corrected: g1.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: update 5-nov-2020: the investigation was re-opened upon receipt of additional information.Below is the original investigation, followed by the full updated investigation.No device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.Monitor ¿ exempt per (b)(4) - known possible complication of joint replacement surgery.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).Based on the inability to find any additional related reports against the provided product code/lot code combination(s) it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4).- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Medical records reviewed (b)(6) 2018 - from a medical perspective, based on the information available, it is not possible to determine if the complaint is product related.Update 5-nov-2020: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.Monitor ¿ exempt per (b)(6) - known possible complication of joint replacement surgery.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Visual examination of the provided x-ray images found no evidence of implant fracture, disassociation, or anything indicative of a device non-conformance.Medical records reviewed 30 aug 2018 - from a medical perspective, based on the information available, it is not possible to determine if the complaint is product related.See attached report.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(6).- without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications at the time it was released for distribution.- the device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.H11 additional narrative: added: g4 pma/ 510(k), h6 health effect (clinical and impact code).Corrected: d4 primary udi number.
Additional Manufacturer Narrative
Product complaint # (b)(4).3 investigation summary: update 5-nov-2020: the investigation was re-opened upon receipt of additional information.Below is the original investigation, followed by the full updated investigation.No device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device(s) was identified.Monitor ¿ exempt per (b)(4) - known possible complication of joint replacement surgery.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).Based on the inability to find any additional related reports against the provided product code/lot code combination(s) it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4).- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Medical records reviewed 30 aug 2018 - from a medical perspective, based on the information available, it is not possible to determine if the complaint is product related.See attached report.Update 5-nov-2020: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.Monitor ¿ exempt per (b)(4) - known possible complication of joint replacement surgery.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Visual examination of the provided x-ray images found no evidence of implant fracture, disassociation, or anything indicative of a device non-conformance.Medical records reviewed (b)(6) 2018 - from a medical perspective, based on the information available, it is not possible to determine if the complaint is product related.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4).- without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications at the time it was released for distribution.- the device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.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.H11 additional narrative: added: b5, h6 health effect - clinical code.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
Medical records received: prior to revision on (b)(6) 2022 patient alleged shortened of leg and felt of electricity going up and down from her left leg and knee.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8239326
• Report Number: 1818910-2019-80567
• Device Sequence Number: 19247059
• Product Code: JWH
• UDI-Device Identifier: 10603295232537
• UDI-Public: (01)10603295232537(17)230131(10)329712
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/13/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 96-0086
• Device Catalogue Number: 960086
• Device Lot Number: 329712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 03/29/2019; 11/17/2020; 08/08/2024; 08/08/2024
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 04/10/2019; 11/19/2020; 08/13/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: Black Or African American