MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIG FEM POST AUG SZ2.5 4MM; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number	96-0846
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Skin Discoloration (2074); Joint Laxity (4526); Physical Asymmetry (4573); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Radiology report (b)(6) 2017 (post revision surgery) reveals the hardware appears to be intact.There is a remote avulsion fracture of the medial aspect of the medial femoral condyle.There is no indication of treatment related to this avulsion fracture.It is unknown when this fracture occurred, during the removal of previous implants or implantation of revision implants.Therefore, this will not be captured as a separate event.Office notes oct 2017 ¿ mar 2020 indicate the patient continues to experience pain, stiffness, weakness, instability, swelling and leg length discrepancy.The patient also states she has skin discoloration on the medial aspect of her lower leg.It is indicated the surgeon has discussed the potential need for future revision, however, there is no indication an additional revision surgery has taken place.It is indicated, however, that the patient has received pain block injections due to her knee pain.A shoe heel lift was provided to help address the leg length discrepancy.Whole body bone scan was performed on (b)(6) 2019 reveals low-level activity diffusely around the left knee prosthetic.No sign of osteomyelitis or fracture.Doi: (b)(6) 2016 (patella).Doi: (b)(6) 2017 (cement, insert, femoral and tibial components; captured in (b)(4)).Doe: unknown.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history review: 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: PFC SIG FEM POST AUG SZ2.5 4MM
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10927397
• Report Number: 1818910-2020-25774
• Device Sequence Number: 871829
• Product Code: JWH
• UDI-Device Identifier: 10603295234203
• UDI-Public: 10603295234203
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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 Model Number: 96-0846
• Device Catalogue Number: 960846
• Device Lot Number: C19898
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REVISION CEM TIB TRAY S2.5; PFC*SIGMA TC3 FEM LEFT S2.5; PFC*SIGMA/OV DOME PAT 3 PEG,32; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; TC3 RP TIBIAL INSERT S2.5,15.0; UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL STEM 75X14MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention