MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI A/P SZ2 8MM RMLL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-12-208

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

Patient Problems Pain (1994); Joint Disorder (2373); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 11/21/2018

Event Type  Injury  

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.(b)(4).

Event Description

It was reported that there was a ruptured posterior cruciate ligament, date of implantation: (b)(6) 2016.Date of revision: (b)(6) 2018 (right knee).

Manufacturer Narrative

H10 additional narrative: corrected: h6.Product complaint #
=
> pc-(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
=
> null.Device history batch
=
> null.Device history review
=
> null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

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.  added: a1, a2 (dob), b5, b7, d2b, d4, g5, h6 corrected: a2 (age).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Event Description

Medical records received were reviewed by a clinician to identify patient harms/product issues.Primary operative notes 12/13/16 indicate the patient received a right uni knee replacement due to medial compartment osteoarthritis and history of acl injury.The surgery was completed without indication of complication by the surgeon.Office notes 11/08/18 indicate the patient is experiencing increasing pain and difficulty with ambulating.Radiographs reveal a somewhat flexed positioning of the femoral component and anterior translation of the tibial component, lateral compartment osteoarthritis is also present.Revision operative notes 11/21/18 indicate the patient received a conversion to right total knee arthroplasty due to pain and posterior cruciate ligament rupture.Upon entering the knee, it was noted that both components were not worn, in good position and not loose.The knee itself was noted to be unstable posteriorly.The surgery was completed without indication of complication by the surgeon.Office notes 01/03/19 indicate the patient is experiencing pain.Radiographs reveal a well-placed arthroplasty with tibial trial present within the joint.Allery testing reveals the patient has a metal allergy, specifically to nickel and vanadium.Revision operative notes 02/06/19 indicate the patient received a right total knee revision due to retained right tibial hardware.Upon entering the joint, scar tissue was encountered and removed.The patella and femoral components were noted to be intact and in good position, they were not revised.The tibial component and retained trial were removed without complication.No indication of deficiency related to the tibial insert or tibial tray.The surgery was completed without indication of complication by the surgeon.Office notes 11/06/19 indicate the patient has experienced lower leg nerve pain since the 02/06/19 surgery.She is experiencing pain, tingling, numbness, swelling, feelings of instability and deceased range of motion relating to her right lower leg.Treatment includes pain medication and physical therapy.No indication of additional surgical intervention.

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.E3 initial reporter occupation: lawyer.

• Brand Name: SIGMA HP UNI A/P SZ2 8MM RMLL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9808285
• MDR Text Key: 182696790
• Report Number: 1818910-2020-07273
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002116
• UDI-Public: 10603295002116
• Combination Product (y/n): N
• PMA/PMN Number: K070849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 1024-12-208
• Device Catalogue Number: 102412208
• Device Lot Number: C75121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR BONE CEMENT; SIGMA HP UNI FEMORAL SZ2 RM/LL
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 81