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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

(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.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9792953
• MDR Text Key: 187546936
• Report Number: 1818910-2020-06921
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• 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

• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/05/2020 Patient Sequence Number: 1