MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S3 15.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2033
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); No Code Available (3191)
Date of Event	03/09/2020
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
Left knee revision; surgeon: (b)(6), primary implant date: (b)(6) 2008.Reason for revision: patient fell 12 months ago, instability noted since this incident.This is the patient's first revision.Good outcome post surgery; no adverse effect on patient.Female patient (b)(6), dob: (b)(6) years old, (b)(6) kgs.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.The complaint was received into the company with the following comment: left knee revision; surgeon: michael anderson; peel health campus, primary implant date: (b)(6) 2008 reason for revision: patient fell 12 months ago, instability noted since this incident.This is the patient's first revision.Good outcome post surgery; no adverse effect on patient.Female patient w.H., dob: (b)(6) 1942, 77 years old, 76kgs.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).Based on the inability to find any additional related reports against the provided product code/lot code combination(s) it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.

• Brand Name: PFC SIGMARP CV TB/IN S3 15.0
• 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: 9874359
• Report Number: 1818910-2020-09125
• Device Sequence Number: 595810
• Product Code: NJL
• UDI-Device Identifier: 10603295240761
• UDI-Public: 10603295240761
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 96-2033
• Device Catalogue Number: 962033
• Device Lot Number: 2423889
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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 TIBIAL TRAY SZ3; PFC*SIGMA C/R POR FEM LF SZ3; PFC*SIGMA/OV DOME PAT 3 PEG,32
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 76