MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL SZ2 RM/LL; EARLY INTERVENTION : KNEE FEMORAL

Catalog Number 102408200

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges patient was revised to address pain, swelling, and a nickel allergy.Update may 04, 2017: legal medical records received.Product/lot information received.Femur, tibia, and insert reported.No revision date or operative records yet available.Date of implantation corrected.Side identified.This complaint was updated on: 05/24/2017.

Manufacturer Narrative

Update may 04, 2017: legal medical records received.The device associated with this reported event was not returned.Findings indicate allergic contact dermatitis to metals, specifically nickel.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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

Manufacturer Narrative

*re-submit.

Event Description

Update 10-2-2017 and 10-5-2017.Legal medical records reviewed.Primary notes (b)(6) 2015 indicate the patient received a right partial knee replacement due to degenerative medial right knee joint disease.Procedure was completed without complication indicated.Ed notes (b)(6) 2015 indicates the patient is post right total knee replacement and presented to the ed with pain, swelling, and redness overlying her surgical incision on her right knee, denies fever.Diagnosis of cellulitis, discharged with cleocin capsules.X-rays post-op follow up (b)(6) 2015 reveal a right medial joint prosthesis in place in satisfactory position.Office note (b)(6) 2015 indicates the patient presented for evaluation of possible delayed hypersensitivity reaction to metals due to developing erythema of the right knee 2 weeks after right partial knee replacement surgery.It should be noted she was treated with antibiotics and the issue resolved.It should also be noted that the patient indicates she develops a rash when wearing fake jewelry.Findings indicate allergic contact dermatitis to metals, specifically nickel.Revision notes 3-15-2016 indicate the patient received a revision right total knee arthroplasty and patella tendon repair due to failed right partial knee replacement due to metal allergy and patellar tendon rupture.Procedure was completed without complication indicated.Office notes (b)(6) 2016 patient presents with no complaints, incision is healing well, post revision.Reportability is correct.Updated 11-1-2017.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: SIGMA HP UNI FEMORAL SZ2 RM/LL
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6590190
• MDR Text Key: 75932397
• Report Number: 1818910-2017-18638
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K070849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102408200
• Device Lot Number: 602039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 73