MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP TROCHLEA SZ5 LT; EARLY INTERVENTION : KNEE FEMORAL

Model Number	1024-03-500
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2020
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
Clinical notification received for revision of left knee patellofemoral joint replacement.Date of implantation: (b)(6) 2009.Date of revision: (b)(6) 2020.(left knee).Treatment: femoral and patellar components.
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.

• Brand Name: SIGMA HP TROCHLEA SZ5 LT
• Common Device Name: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11193097
• Report Number: 1818910-2021-01386
• Device Sequence Number: 11698645
• Product Code: NPJ
• UDI-Device Identifier: 10603295001652
• UDI-Public: 10603295001652
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 1024-03-500
• Device Catalogue Number: 102403500
• Device Lot Number: DA6MG4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1818910-12/15/2017-004-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC*SIGMA/RD/DOME PAT 3PEG,38.; SIGMA HP TROCHLEA SZ5 LT.; PFC*SIGMA/RD/DOME PAT 3PEG,38; SIGMA HP TROCHLEA SZ5 LT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 102