MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE PATELLA

Catalog Number UNK KNEE PATELLA

Device Problem Loss of Osseointegration (2408)

Patient Problems Myocardial Infarction (1969); Pain (1994); Thrombosis (2100); No Code Available (3191)

Event Date 05/05/2011

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.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.(b)(4).

Event Description

An article/literature was received entitled "revision of failed unicompartmental knee replacement to total knee replacement.¿ literature article "revision of failed unicompartmental knee replacement to total knee replacement" by daud t.S.Chou et al.Published by the knee was reviewed.The article purpose: to review patients who had a revision total knee replacement for failed unicompartmental knee replacement.The article reports: between 2001 and 2010, one hundred and thirty-two unicompartmental knee replacements were performed at the authors' institute for this study.The prosthesis survival rate was 89 percent at two years and 77 percent at 5 years.The predominant cause of failure was aseptic loosening.Other reasons for revision as noted in clinical documentation, included persistent pain, malalignment, and the progression of symptomatic osteoarthritis in another compartment.Two patients had myocardial infarctions which were treated medically, two developed deep vein thrombosis of their lower limb.All patients were successfully treated and discharged home.The patella was resurfaced in two cases so it will be coded for.Cement was used in all cases although no manufacturer was specified.The authors don't specify which complications are associated with depuy products, therefore product quantities are not able to be obtained.Depuy products involved: pfc.Complications: aseptic loosening, mispositioning, pain, myocardial infarction, dvt, surgical intervention.

• Brand Name: UNKNOWN KNEE PATELLA
• Type of Device: KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9492992
• MDR Text Key: 174602735
• Report Number: 1818910-2019-123985
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE PATELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention