MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LTSZ2.5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0008
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	03/11/2021
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
Study: (b)(6).Clinical adverse event received for scar surrounding the patellar button : adhesions.Event is serious and is considered moderate.Event is definitely not related to device and is probably related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2021, (left knee).Treatment: arthroscopy of left 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 at this time.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).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
On (b)(6) 2021, patient presented for clinical visit with painful left knee, catching over the anterior aspect of her knee, diagnosis, patellar clunk with abundant scar tissue around patellar button per mri.Plan is to address with an arthroscopy, on (b)(6) 2021, presenting with pain, and the equivalent of a patellar clunk, status post left total knee arthroplasty, with post-op diagnosis of abundant scar of the suprapatellar pouch, undersurface of quadriceps tendon, and in the parapatellar tendon area, left knee.Patient received an arthroscopic resection of scar at the peripatellar area, undersurface of the quad tendon suprapatellar pouch, left knee.The patellar button and prosthesis still appeared pristine.There were no complications associated with this procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 11594439
• Report Number: 1818910-2021-06580
• Device Sequence Number: 3402761
• Product Code: JWH
• UDI-Device Identifier: 10603295232001
• UDI-Public: 10603295232001
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 03/19/2021

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: 96-0008
• Device Catalogue Number: 960008
• Device Lot Number: D19092256
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 05/17/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/25/2021; 05/18/2021
• 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: DEPUY CMW 1 40G; DEPUY CMW 1 40G; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA PLI XLK INS 2.5 10MM; DEPUY CMW 1 40G; DEPUY CMW 1 40G; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA PLI XLK INS 2.5 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 82