MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA FEM POST AUG SZ3 4MM; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960866
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had primary tkr (lcs with duofix femur) (b)(6) 2008.Has had ongoing issues since with pain, swelling & loosening.Had partial revisions in (b)(6) 2011 & (b)(6) 2012 for pain & loosening.Patient presented again in 2017 with pain & bone scans suggesting loosening - revised entire construct to tc3 with mbt sleeves & stems.Presented again in 2023 with pain.Bone scan suggested loosening so revised to attune revision with stems & sleeves.Implants weren't grossly loose and required some work (flexible osteotomes around metaphyseal sleeves & slap hammer attachments) to remove.Doi: (b)(6) 2008.Doe: (b)(6) 2023.Affected side: unknown.
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : 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.Based on the inability to find any additional related reports against the provided product code/lot code 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.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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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: a.What was the affected side? right knee.B.Which implants were loose and what interface(s)? none were obviously loose on removal however showed loosening on bone scan; zone 2 metaphyseal sleeves were fixed & required significant work to loosen.Some loosening around zone 1 femur cement bone interface.

• Brand Name: PFC SIGMA FEM POST AUG SZ3 4MM
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17459972
• Report Number: 1818910-2023-16051
• Device Sequence Number: 7189711
• Product Code: JWH
• UDI-Device Identifier: 10603295234302
• UDI-Public: 10603295234302
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 08/04/2023

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: 960866
• Device Lot Number: C83032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 09/05/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/21/2023; 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• 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: DEPUY CMW 2G 40G.; MBT REVISION CEM TIB TRAY SZ 3.; MBT TRAY SLEEVE POR M/L 45MM.; PFC SIGMA FEM POST AUG SZ3 4MM.; PFC*SIGMA DI AUG16MMCO,SZ3RGHT.; PFC*SIGMA DI AUG16MMCO,SZ3RGHT.; PFC*SIGMA TC3 FEM RT SZ3.; SIGMA FEM ADAPTER 5 DEGREE.; SIGMA FEM ADAPTER NEUTRAL BOLT.; TC3 RP TIBIAL INSERT S3,10.0.; UNIVERSAL FEM SLV FUL POR 40MM.; UNIVERSAL STEM 75X14MM FLUTED.; UNIVERSAL STEM 75X16MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 67 KG