MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER CERAMIC PINNACLE; CERAMIC ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER CERAM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 "change of pelvic sagittal tilt after total hip arthroplasty in patients with bilateral crowe type iv developmental dysplasia of the hip " written by bohan zhang, md, yinqiao du, md, jingyang sun, md, junmin shen, md, tiejian li, md, yonggang zhou, md, phd published by orthopaedic surgery accepted on (b)(6) 2022 was reviewed.The article's purpose was to explore and analyze the change of pelvic sagittal tilt (pst) after total hip arthroplasty (tha) in patients with bilateral crowe type iv developmental dysplasia of the hip (ddh).The study retrospectively evaluated 43 patients with bilateral crowe type iv ddh undergoing tha from (b)(6) 2008 to (b)(6) 2019 who were followed up for 12 months postoperatively.The significant change of pelvic sagittal posterior tilt in patients with bilateral crowe type iv ddh might be a significant phenomenon after tha, which could occur in 6 months postoperatively.All patients utilized the s-rom modular cementless prosthesis and the cementless acetabular cup of ceramic on ceramic bearing (pinnacle) from depuy synthes.The article details 3 post-surgical complications including two hip dislocations requiring open reductions.A periprosthetic fracture of the right femur occurred in one hip as well, treated via open reduction and enhanced internal fixation.All patients recovered with no further complications.

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, post market surveillance, 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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP ACETABULAR LINER CERAMIC PINNACLE
• Type of Device: CERAMIC ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17161680
• MDR Text Key: 317632489
• Report Number: 1818910-2023-12511
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

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 LINER CERAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 06/23/2023
• 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