MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-043
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
Date of Event	06/29/2020
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
Clinical adverse event received for recurrent hemarthrosis.Event is not serious and is considered mild.There is a remote possibility the event is related to device and is possibly related to procedure.Date of implantation: (b)(6) 2007.Date of revision: (b)(6) 2018 (insert).Date of event (onset): (b)(6) 2020.(right knee).Treatment: 80cc of blood was aspirated and sent for cultures; antibiotic/clindamycin loading dose twice.
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 related reported incidents against the provided product code/lot number combination 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.
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.H10 additional narrative: corrected: h6 (patient code).Removed: (3191) minor injury and corrected it with (3191) serious injury.
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.H10 additional narrative: added: b5, d6b and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d2 (age).
Event or Problem Description
On (b)(6) 2020, the patient had a revision right total knee arthroplasty, both the femoral and tibial components to address aseptic loosening of the femoral component and recurrent hemarthrosis.Depuy components including depuy cement were used during this procedure.Femoral component was noted to be loose, but no interface of loosening provided.
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 related reported incidents against the provided product code/lot number combination 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.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.H10 additional narrative: added: h6 (impact code).

• Brand Name: SIG RP AOX CRV INS SZ4 15
• 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: 10286074
• Report Number: 1818910-2020-16116
• Device Sequence Number: 13625698
• Product Code: NJL
• UDI-Device Identifier: 10603295076223
• UDI-Public: 10603295076223
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/06/2020

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: 1961-92-043
• Device Catalogue Number: 196192043
• Device Lot Number: 8169967
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/06/2020; 08/18/2020; 01/08/2021; 05/20/2021
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 07/20/2020; 08/19/2020; 01/29/2021; 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 83