MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2020

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, ¿minimum 5 year follow-up of clinical and radiographic results of cemented acetabular components with an interface bioactive bone cement technique in primary cemented total hip arthroplasty¿ by shuichi miyamoto, et al, published by archived of orthopaedic and trauma surgery (2020), https://doi.Org/10.1007/s00402-020-03638-6, 11 pages, was reviewed.The purpose of this study was to evaluate the midterm clinical and radiological results of fixing the acetabular component using the interface bioactive bone cement technique in primary cemented tha for 193 hips implanted using a variety of surgical approaches and devices.All cement used was antibiotic loaded with 0.5g cefazolin per 40g bone cement.The authors used both depuy and competitor cement and devices and allograft.The results did not specify manufacturer.The actual number of depuy products associated with the adverse events is unknown.Depuy components used in the study: 35 charnley elite plus ogee hips including a cemented polyethylene cup, femoral stem, and femoral head 19 charnley ogee hips including a cemented polyethylene cup, femoral stem, and femoral head depuy endurance antibiotic loaded cement was utilized in 45 hips.Results: 1 revision for deep infection of the femoral component at 9 years.1 revision for deep infection and osteolysis of the acetabular and femoral components.The authors note this patient had noted radiolucent lines but no intraoperative indication of acetabular or femoral component of loosening.The authors directly attributed the osteolysis to the deep infection.1 femoral revision due to a periprosthetic femoral fracture at 5 years.2 cup revision to treat cup migration at 1 year and 7 months, respectively.Radiographic results: 47 patients, who were not revised, had evidence of radiolucent lines in at least one zone- no treatment was provided.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11057778
• MDR Text Key: 223712860
• Report Number: 1818910-2020-27554
• Device Sequence Number: 1
• Product Code: KWA
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention