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

Catalog Number UNK HIP ACETABULAR CUP PINNACL

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

Patient Problems Anemia (1706); Hematoma (1884); Hemorrhage/Bleeding (1888); Muscular Rigidity (1968); Pain (1994); Perforation of Vessels (2135); Pseudoaneurysm (2605); Thromboembolism (2654); Swelling/ Edema (4577)

Event Date 05/25/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: crown tjl, sheridan ga, bengoa f, fransen bl, lawlor dk, clarkson pw, greidanus nv.Chronic pseudoaneurysm and anterior dislocation after total hip arthroplasty complicated by arterial injury: a case report.Jbjs case connect.2022 may 25;12(2).Doi: 10.2106/jbjs.Cc.22.00054.Pmid: 36099455.Objective and methods: in this case report, we report on one such case presenting with chronic leg swelling and ultimately a prosthetic hip dislocation due to a mass effect of an underlying pseudoaneurysm.Patient history: patient received a right pinnacle/trilock mop tha with one acetabular bone screw for unknown reasons.The authors note the primary procedure was complex due to the patient¿s bmi (57) requiring a direct lateral approach.At some point during the primary procedure.There was a femoral artery injury requiring primary closure which resulted in a small 7.5 x 6 cm soft tissue mass in the anterior compartment.Within two weeks, the patient reported pain and right leg swelling that worsened over the next 18 months.Present case: a 64-year-old male patient presented with right leg pain, increasing difficulty walking, and skin changes secondary to chronic lymphedema 18-month status-post a pinnacle/trilock tha.Imaging revealed a large hemipelvis mass measuring 25 x 15 x 29 cm within the joint.The mass effect caused an anterolateral dislocation of the construct.A ct guided biopsy of the mass identified a large chronic thrombus/pseudoaneurysm.Patient received a right total construct removal as well as evacuation of 30 ml of thrombus.During the procedure, the vascular surgeon noted frank venous bleeding from an abnormal branch of the femoral vein, so the decision was made to forego implantation of a revision construct.Histological analysis of the evacuated tissue confirmed the presence of a hematoma.Postoperatively, the patient¿s hemoglobin dropped dramatically requiring multiple blood transfusions due to a retroperitoneal hematoma caused by disruption of the external iliac artery resulting in a pseudoaneurysm.The patient received a left-to-right femoral-femoral bypass with a laparotomy, decompression, and evacuation of the hematoma, then a repeat procedure to reconstruct the femoral artery.Due to the patient¿s fragile tissues, there will be no revision arthroplasty.At the time of this writing, the patient has made a full recovery.Devices associated with the event: pinnacle cup with one dome screw trilock femoral stem metal femoral head poly acetabular liner.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

• Brand Name: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18967346
• MDR Text Key: 338438412
• Report Number: 1818910-2024-06035
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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 PINNACL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR LINER POLY PINNACLE; UNK HIP BONE SCREW; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male