MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S3 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2032
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/10/2009
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
On (b)(6) 2009, the patient underwent a right knee revision with tibial insert exchange to address dislocation, instability, and correction of patella bone fracture.The patient was post infection and an irrigation and debridement was also performed.The patella fracture was indicated as happening on the day of the procedure due to a fall.It is noted the previous operative note also indicated a patella bone fracture that was not addressed at the time of the first procedure.The surgeon indicated partial expulsion of the tibial insert.The patella component was well-fixed and retained.There were no indicated intra-operative complications.
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.

• Brand Name: PFC SIGMARP CV TB/IN S3 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11398265
• Report Number: 1818910-2021-04086
• Device Sequence Number: 13757983
• Product Code: NJL
• UDI-Device Identifier: 10603295240754
• UDI-Public: 10603295240754
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2009
• 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): 02/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-2032
• Device Catalogue Number: 962032
• Device Lot Number: 2673131
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/25/2021
• 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 CEM KEEL TIB TRAY SZ3; PFC*SIGMA C/R NPOR FEM RT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; MBT CEM KEEL TIB TRAY SZ3; PFC*SIGMA C/R NPOR FEM RT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 88