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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Injury (2348); Osteolysis (2377); No Code Available (3191)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

Pcf and medical records received.After review of medical records, patient was revised to address adverse local tissue reaction with metallosis after right total hip arthroplasty with significant lysis and greater trochanteric fracture along with pseudotumor.Operative notes stated that radiographs showed osteolysis and lucency under acetabular shell as well as elevated esr and crp.An aspiration of the hip revealed white blood cell count greater than 6000 as well as a left shift.A ct scan showed possibility of pseudotumor and elevated cobalt and chromium levels.Incision was made laterally, dissected down to the iliotibial band to gluteus medius vastus lateralis and found obvious greater trochanteric fracture that was comminuted as well as loss of the calcar when the stem was examined.There was a tremendous amount of metal stained tissue.The bone also appeared stained with metal debris.When the head was removed , the trunnion was exposed with significant amount of metal oasis.Attention was in acetabular component, significant amount of anteversion was noted.There was a large area of pseudotumor and was excised.There was also a fluid on the hip.There was a significant erosion of the acetabulum with loss of mainly the anterior wall.No indication of infection.There was significant amount of posterior impingement noted and the trunnion of the femoral stem had been impinge posteriorly on the cup for many years.Doi: (b)(6) 2008; dor: (b)(6) 2018 right hip.

Manufacturer Narrative

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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9792956
• MDR Text Key: 187546805
• Report Number: 1818910-2020-06918
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• 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: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR