MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI INS SZ2 7MM LM/RL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102453207

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 03/31/2017

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

*re-submit.

Event Description

Update 10-2-2017 and 10-4-2017.Legal medical records reviewed.Primary procedure notes (b)(6) 2015 indicate the patient received a left knee medial unicondylar arthroplasty due to left knee advanced medial compartmental arthritis and loss of joint space.Procedure was completed without complication indicated.X-rays post-op follow up 6-16-2015 reveal a left medial joint prosthesis in place in satisfactory position.Procedure notes 7-9-2015 indicate the patient received a left knee arthroscopy with partial medial synovectomy due to pain, medial synovial plica, scar tissue.Procedure was completed without complication indicated.Ed notes (b)(6) 2015 indicate the patient is status post total knee revision on the left and presents to the ed with sharp left calf pain.Upon exam, there was no evidence of dvt; small baker¿s cyst present in left popliteal fossa.Ct left knee (b)(6) 2015 due to left knee swelling with pain and elevated sedimentation rate.Findings include: small suprapatellar joint effusion, pre-patella subcutaneous soft tissue swelling that may be related to edema, cellulitis or post-traumatic changes; calcification of the quadriceps and patellar tendons suggesting chronic tendonitis.Office visit (b)(6) 2015 indicates the patient presented with burning constant pain and swelling of the left knee, exam revealed small effusion; diagnosis of inflammatory arthropathy.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.Office notes (b)(6) 2015 recommendation for revision to titanium total knee due to nickel allergy.Revision notes (b)(6) 2016 indicate the patient received a revision left total knee arthroplasty due to failed left unicompartmental knee arthroplasty.Upon entering the joint, the surgeon notes that both the femur and tibial components appeared to be well secured.There were no signs of loosening or unusual wear.Procedure was completed without complication indicated.Progress note (b)(6) 2016 reveals the patient has no complaints, denies pain, 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 INS SZ2 7MM LM/RL
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6590210
• MDR Text Key: 75932846
• Report Number: 1818910-2017-18641
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,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: 102453207
• Device Lot Number: 605229
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 73