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

Catalog Number UNK HIP ACETABULAR CUP

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

Patient Problems Thrombosis (2100); No Code Available (3191)

Event Date 03/17/2020

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.

Event Description

The literature article entitled, " bilateral acetabular fractures treated with delayed total hip arthroplasty" written by jessica h.Heyer, md, savyasachi c.Thakkar, md, kyle zittel, ba, and james e.Tozzi, md published by arthroplasty today made available online 17 march 2020 was reviewed.The article's purpose was to report on a case of a (b)(6) year old male who experienced bilateral acetabular fractures and underwent staggered bilateral thas.Left hip was performed first then right within 2 days of initial procedure.Article reports similar techniques were utilized and that products were depuy gription cup fixated by 3 screws and summit stem.The article does not identify or refer to the bearing surfaces.Intraoperative procedure was uneventful and patient made full post op recovery.Only adverse event reported was a deep vein thrombosis in left common femoral vein detected approximately 2 months post op and treated with 3 months of 20 mg xarelto.Figures 1-3 provide radiographic images prior to implantation, figure 4 provides photographic images of procedure, and figures 5-6 provide radiographic images post procedure for illustrative purposes.Depuy products: gription cup (one for left and one for right hip), summit stem (one for left and one for right hip).Adverse events: deep vein thrombosis (treated by 3 months of 20 mg xarelto).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The provided x-ray and photographic images have been reviewed.All images are prior the patient experiencing any adverse issue.Nothing indicative of a product problem is identified.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.

• 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: 10592377
• MDR Text Key: 208723334
• Report Number: 1818910-2020-20968
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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 HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR