MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL INSERT

Catalog Number UNK KNEE TIBIAL INSERT

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

Patient Problems Hematoma (1884); Pain (1994); Loss of Range of Motion (2032)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # :(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

Literature article entitled ¿metaphyseal sleeves in arthroplasty of the knee: a suitable tool in management of major metaphyseal bone loss" written by christian lycke, dirk zajonz, alexander brand, torsten prietzel, christoph-e.Heyde, andreas roth and mohamed ghanem by der orthopäde, october 21, 2020 was reviewed.The article's purpose was to ¿examine the clinical outcome following revision arthroplasty of the knee joint and severe arthrosis with metaphyseal bone defects and instability using metaphyseal sleeves.¿ data was compiled from 16 patients: 9 females and 7 males.The average age at surgery of the patients was 76.5±12 years and 79 ±7 years, respectively.Cement manufacturer was not provided.4 patients with primary arthrosis along with severe metaphyseal bone defects and varus deformity.12 patients received revision arthroplasty of the knee and the primary implant manufacturers were not provided and this will not be captured.Depuy products: lcs complete¿ revision knee system with tibial and femoral metaphyseal sleeves lcs® valgus-varus constrained vvc or s-rom® rotating hinge knee system.Please note - specific implants per patient were unspecified.Adverse events relating to the 12 revision patients: patient 1: recurring effusions, pain ¿ conservative treatment.Patient 2: prolonged wound healing, pain ¿ conservative treatment.Patient 3: no noted adverse events.Patient 4: no noted adverse events.Patient 5: prolonged pain ¿ conservative treatment.Patient 6: prolonged pain ¿ conservative treatment.Patient 7: recurring effusions, pain ¿ conservative treatment.Patient 8: prolonged wound healing, pain ¿ conservative treatment.Patient 9: patellar tendon rupture, pain (17 months out) ¿ surgical patellar tendon graft.Patient 9: retropatellar arthrosis, pain (44 months out) ¿ surgical retropatellar replacement patient 10: prol.Onged wound healing, pain ¿ conservative treatment.Patient 11: postoperative hematoma, pain ¿ puncture and drainage or surgical revision.Patient 12: exacerbation of partial peroneal paralysis, pain ¿ conservative treatment.Adverse events relating to the 4 primary implantation patients: patient 1: lymphedema, effusions, pain ¿ conservative treatment.Patient 2: no noted adverse events.Patient 3: no noted adverse events.Patient 4: prolonged wound healing, pain ¿ conservative treatment.Additional non-specified adverse events without patient correlation: hematoma, range of motion extension deficit and pain - puncture and drainage or surgical revision please note, for the 2 events involving hematoma ¿ it is unclear which patient received a puncture drainage and which received the revision.Therefore, both treatments will be captured for both patients.Also, there were no findings for the revised components.All radiographic images within the article images are for unknown knee implants.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN KNEE TIBIAL INSERT
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12285397
• MDR Text Key: 265585964
• Report Number: 1818910-2021-17213
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention