MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ2 L; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-40-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
The patient was revised to address knee pain and subluxation.The surgeon decided to remove her primary knee and replace with a more constrained knee prosthesis.The surgeon removed the original components and replaced with attune revision implants with sleeve and stems.No one mentioned a problem with the original implants but did notice the poly looked worn on the posterior side both medial and lateral sides.They were able to recover component sizes but the hospital buys their own cement so they do not know the manufacturer.Doi: (b)(6) 2013, dor: (b)(6) 2020, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: 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.

• Brand Name: SIGMA PS CEM FEM SZ2 L
• 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: 10530964
• Report Number: 1818910-2020-20006
• Device Sequence Number: 3118958
• Product Code: JWH
• UDI-Device Identifier: 10603295075028
• UDI-Public: 10603295075028
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 1960-40-200
• Device Catalogue Number: 196040200
• Device Lot Number: 295548
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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 CEM KEEL TIB TRAY SZ2.5; PFC SIGMARP STB TB IN 2 15.0; SIGMA PS CEM FEM SZ2 L; MBT CEM KEEL TIB TRAY SZ2.5; PFC SIGMARP STB TB IN 2 15.0; SIGMA PS CEM FEM SZ2 L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR