MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FE RT SZ2.5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/11/2021
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
(b)(6).Clinical adverse event received for patellar tendon rupture: extensor mechanism insufficiency.Event is serious and is considered severe.Event is definitely not related to device and there is a remote possibility that the event is related to procedure.Date of implantation: (b)(6) 2021; date of event (onset): (b)(6) 2021; (right knee).Medical records were reviewed.The patient underwent bilateral knee replacements without complications on (b)(6) 2021 utilizing depuy cement.Bilateral patellas were resurfaced at that time.On (b)(6) 2021, the patient was rising from a low toilet when she felt a pop and immediate pain in the right knee.Workup revealed patella alta with a small chip of bone off of the inferior pole of the patella leading to a diagnosis of a complete patella tendon rupture with avulsion fracture.Upon xray review, it was also noted that there was anterior tilt of the patella but this was not noted within the operative notes of the patella tendon repair.The patient was unable to lift her leg at the time.On (b)(6) 2021, a right patella tendon repair was completed.Surgeon notes evidence of a hematoma and a small area of compromised skin where it looked like the wound was starting to drain that required excision.
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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• 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: 11984288
• Report Number: 1818910-2021-12464
• Device Sequence Number: 4760446
• Product Code: JWH
• UDI-Device Identifier: 10603295232070
• UDI-Public: 10603295232070
• 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: 2021
• 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): 05/18/2021

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: 96-0018
• Device Catalogue Number: 960018
• Device Lot Number: D19111346
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA PLI XLK INS 2.5 12.5MM; DEPUY CMW 1 40G; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA PLI XLK INS 2.5 12.5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82