MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ5 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-50-500
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)
Date of Event	10/26/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Revision operative notes 10/26/2015 indicate the patient received a right total knee revision due to pain, stiffness and hardware failure.Upon entering the joint, significant scar tissue was encountered and removed.The bolt was found broken and had fallen out of the intracondular notch.The broken portion of the bolt was still in the sleeve.The femoral component was noted to be loose.Femoral components and insert were revised.The surgery was completed without indication of complication by the surgeon.Products implanted at this revision are located on page 13-15.Doi: (b)(6) 2013.Dor: (b)(6) 2015.Right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Update 31aug2021.Update 10 aug 2021 received did not have any additional details to be added in investigation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.

• Brand Name: SIGMA PS CEM FEM SZ5 R
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10542095
• Report Number: 1818910-2020-20262
• Device Sequence Number: 436873
• Product Code: JWH
• UDI-Device Identifier: 10603295075165
• UDI-Public: 10603295075165
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1960-50-500
• Device Catalogue Number: 196050500
• Device Lot Number: 340528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 09/08/2021
• 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 SZ 4; MBT TRAY SLEEVE POR M/L 53MM; PFC SIGMARP STB TB IN 5 10.0; PFC*SIGMA DIS AUG 4MM,SZ5,RGHT; PFC*SIGMA DIS AUG 4MM,SZ5,RGHT; SIGMA FEM ADAPTER 7 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL STEM 115X12MM FLUTED; UNIVERSAL STEM 75X10MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention