MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT-CEMENT RESTRICTOR

Catalog Number UNK HIP

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

"literature article entitled, ¿efficacy of two types of femoral cement restrictor in total hip arthroplasty¿ by j.A.Jeffery, published by hip international (1997), vol.7, no.1, pp.28-33, was reviewed.In this article, a standard plastic restrictor (hardinge type) was compared with a bone plug restriction method in a randomized, prospective trial of 50 patients.Implanted product: charnley cup, head, and stem.The stem was cemented with a hardinge type plastic cement restrictor (depuy).The cement used was a competitor product.25 patients received the cement restrictor and 25 received a cancellous bone plug that was cut using a depuy wroblewski bone block cutter instrument.Results: there was cement leakage past the plastic restrictor seen in 5 patients.The authors attribute the leakage to migration of the plastic bone restrictor.The authors were unable to determine if there was any cement leakage in the bone block because the bone black was radiolucent.The authors do not list any patient consequences, revisions, or adverse events in the text of the article.There were no product problems attributed to the instrument, stem, cup, or head.Captured in this complaint: 5 hardinge type cement restrictors for device migration.".

• Brand Name: UNKNOWN HIP IMPLANT-CEMENT RESTRICTOR
• Type of Device: HIP IMPLANT-CEMENT RESTRICTOR
• 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 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9256914
• MDR Text Key: 188470712
• Report Number: 1818910-2019-113124
• Device Sequence Number: 1
• Product Code: JDK
• 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,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2019
• 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