MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK CEMENT RESTRICTOR/PLUG

Catalog Number UNK CEMENT RESTRICTOR

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2006

Event Type  malfunction  

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, ¿a study of the elite plus femoral component using radiostereometric analysis,¿ by b.Derbyshire,, et.Al., published by the journal of bone and joint surgery (2007), vol.89-b, no.6, pp.730-735, was reviewed.The purpose of this study was to report on three-year radiostereometric analysis (rsa) study of the elite plus femoral component on 25 patients undergoing primary total hip replacement between february 2000 and april 2001.All patients received a cemented charnley elute plus femoral stem and cemented all poly charnley flanged cup utilizing depuy cmw 2 cement as well as a depuy femoral head.In 15 patients, the surgeon placed a femoral cement restrictor with a marker to measure cement mantle migration in femoral stems.All patients received consecutive radiostereometric exams to measure the rate of migration over a three-year follow-up.There were no reports of revision surgery related to the hips in this study.The authors concluded that low-viscosity cement and surgical technique are contributing factors in the migration of the low-friction charnley hip.Patient specific results: patient 16, female: radiographic evidence of femoral stem, cement mantle, and cement restrictor migration- no treatment provided.Patient 17: radiographic evidence of proximal and varus rotation of the femoral stem, femoral cement, and femoral cement restrictor.There was radiographic evidence of poly cup wear as evidenced by migration of the femoral head into the cup.There is no indication of treatment.The authors note that patient 17 had a revision of a charnley cup secured with unknown cement due to polywear on the contralateral hip on an unknown date, which is captured in this complaint.Patient 19: radiographic evidence of proximal distal stem migration, in addition to cement mantle and cement restrictor migration.No treatment provided.Non-patient specific results: 21 radiographic identifications of stem, cement mantle migration and/or rotation.The mean migration was 0.25 mm and mean internal rotation of 1.3 degrees.Mean cement mantle migration of 0.19 mm with numerous reports of radiolucent lines around the stem and/or cup.No treatment provided.12 radiographically identified cement restrictor migrations- no treatment provided.21 all poly cups demonstrated some poly wear as evidenced by the migration of the femoral head into the cup- mean migration into the cup was 0.80 mm.No treatment provided.

Manufacturer Narrative

Product complaint #(b)(4).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 number 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.Device history lot: a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

• Brand Name: UNK CEMENT RESTRICTOR/PLUG
• Type of Device: CEMENT RESTRICTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12353432
• MDR Text Key: 267655726
• Report Number: 1818910-2021-18350
• Device Sequence Number: 1
• Product Code: HTY
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT RESTRICTOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1