MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PLI XLK INS 2.5 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number 1581-02-110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)

Event Date 03/15/2022

Event Type  Injury  

Event Description

Clinical adverse event received for swelling, hemarthrosis.Event is not serious and is considered mild.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2022.Date of event: (b)(6) 2022.(right knee).Treatment: aspiration/drainage and oral medication (celebrex).

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.

Event Description

(b)(6) 2022: the patient underwent a successful right primary total knee arthroplasty using pfc sigma components and depuy 1 cement.The patella was resurfaced.(b)(6) 2022: the patient has increasing pain and discomfort, primarily over the medial and lateral aspect of the patella.Moderate effusion was noted.An aspiration was done, which showed bloody fluid.He was also treated with antibiotics and celebrex.(b)(6) 2022: the patient was squatting in therapy and felt a pop with increasing pain.Xray show a small nondisplaced fracture across the inferior pole of the patella.This is treated with a brace for six weeks.(b)(6) 2022: the patellar fracture remains stable.The patient c/o stiffness from wearing the brace and was told he can now do range of motion and walking.It is questionable whether he avulsed a little bit of the tendon from the bone.No further intervention planned at this time outside of slowly increasing his activity level.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - the device associated with this report was not received for examination.Based on the visual analysis of the provided photographic evidence for, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.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.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.

• Brand Name: SIGMA PLI XLK INS 2.5 10MM
• Type of Device: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15966104
• MDR Text Key: 305342137
• Report Number: 1818910-2022-25147
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295062431
• UDI-Public: 10603295062431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082500
• 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
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1581-02-110
• Device Catalogue Number: 158102110
• Device Lot Number: 9798063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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.; PFC*SIGMA C/R NPOR FEM RT SZ 3.; PFC*SIGMA/OV/DOME PAT 3PEG,35.; SIG MOD TIB TRAY CEM COCR 2.5.; SIGMA PLI XLK INS 2.5 10MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White