MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-50-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	01/25/2021
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
It was reported that the patient had pain in flexion.The knee was opened up and scar tissue was released and removed.The surgeon decided to leave the implants as they were.No implants were exchanged and closure of the incision was performed.No surgical delay.Doi: unknown, doe: (b)(6) 2021, unknown affected side.
Event or Problem Description
Affected side: right knee.
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 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed h10 additional narrative: added: b5.

• Brand Name: SIGMA PS CEM FEM SZ4 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: 11289932
• Report Number: 1818910-2021-02543
• Device Sequence Number: 3543204
• Product Code: JWH
• UDI-Device Identifier: 10603295075141
• UDI-Public: 10603295075141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 1960-50-400
• Device Catalogue Number: 196050400
• Device Lot Number: 8921884
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/11/2021
• 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: COMPETITOR PATELLA; MBT REVISION CEM TIB TRAY SZ 3; PFC SIGMARP STB TB IN 4 12.5; SIGTIBCEMSTM 13X30 1.5/2/2.5/3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR