MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/OV/DOME PAT 3PEG,41; SIGMA KNEE PRIMARY : KNEE PATELLA

Model Number 96-0103

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/09/2023

Event Type  Injury  

Event Description

Clinical adverse event received for recurrent hemarthrosis.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2014.Date of revision: unk.Date of event: (b)(6) 2023.(left knee).Treatment: revision; revised components not specified.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Due to new information noting that only the insert was revised, the previously reported tibial tray, femoral component, cement, and patella will now be not reportable as the surgeon elected not revise them.It is reasonable to conclude those components that were not revised were not part of the reason for the revision.Due to this, depuy synthes joint reconstruction considers the device on this report to be not reportable as there is no allegation of deficiency or patient harm, additional follow up is being conducted.Further updates will only be provided if additional information is received that changes the regulatory determination.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.

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: b1 (product problem), b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h1 (type of reportable event), h6 medical device problem code.

Event Description

Operative notes received.On (b)(6) 2014, the patient underwent a left primary knee arthroplasty with no complications.On (b)(6) 2023, the patient underwent a revision of the tibial insert secondary to recurrent hemarthrosis.Prior to surgery, he had multiple episodes of nontraumatic swelling and pain.He was aspirated 3 times prior to the revision.Intraoperatively, hypertrophic synovium was identified due to possible impingement between the components causing bleeding.Posterolateral flexion instability was also identified.There was also lateral instability requiring release of the superficial mcl and an upsize of the insert.A wear stripe was identified on the patella but it was not revised.

• Type of Device: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17154409
• MDR Text Key: 317450543
• Report Number: 1818910-2023-12462
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295232636
• UDI-Public: 10603295232636
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2023

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
• Device Operator: Health Professional
• Device Model Number: 96-0103
• Device Catalogue Number: 960103
• Device Lot Number: D14063583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 06/14/2023; 06/26/2023; 08/03/2023
• Supplement Dates FDA Received: 06/26/2023; 07/14/2023; 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ5; PFC*SIGMA C/R NPOR FEM LT SZ5; SIG RP AOX CRV INS SZ5 10
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White