MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA MOD TIB TRAY CEM SZ2; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-6022
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: (b)(6).Clinical notification received for revision to address stress reaction.Date of implantation: (b)(6) 2003.Date of revision: (b)(6) 2021 (right knee).Treatment: revision of the tibial insert.Clinic visit (b)(6) 2021: patient presents with right knee pain, swelling, warmth, and crepitus after several falls 20 years status post bilateral knee implantation.Radiographic images identify an anteriorly distracted tibial insert and an area of asymptomatic tibial osteolysis.Plan is made to revise the insert, as the tibial and femoral components are well-fixed and intact.Dor: (b)(6) 2021: patient received a right knee insert revision to treat pain and limited range of motion secondary to displacement of the tibial insert.Upon entering the joint, the surgeon identified black stained synovium and performed a complete synovectomy.The insert was displaced anteriorly.The surgeon notes there was no wear or problems with the locking mechanism on the tray.The tray was well-fixed and retained.The issue was resolved by replacing the old insert with a new insert that was one size larger.The insert snapped into position and a rom check confirmed it was not displaceable.The procedure was completed without complications.Doi: unknown.Dor: (b)(6) 2021; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.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: PFC SIGMA MOD TIB TRAY CEM SZ2
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13658525
• Report Number: 1818910-2022-03960
• Device Sequence Number: 1869693
• Product Code: JWH
• UDI-Device Identifier: 10603295216773
• UDI-Public: 10603295216773
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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: 86-6022
• Device Catalogue Number: 866022
• Device Lot Number: 1058701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2002
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC SIGMA STAB INS SZ2 10MM; PFC*SIGMA C/S NPOR FE RT SZ2.5; SIGMA PATELLA OVAL DOME 3 PEGGED 35MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 88 KG