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

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Local Reaction (2035); Joint Disorder (2373); Osteolysis (2377); No Code Available (3191)

Event Date 10/15/2018

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.(b)(4).Initial reporter occupation: lawyer.

Event Description

Operative notes reported that there was a large metal-stained synovium and pseudocapsule extending from glut medius tendon to the trochanteric bursa.Operative finding reported large area of superficial metallosis in the region of the trochanteric bursa, moderate synovial hypertrophy, "during exposure, it was noted that there was notching in the femoral component on the superolateral neck, that coincided with a notched area of the acetabular shell (not liner) in the superolateral region indicating neck- cup impingement and minimal head ball or liner wear.There was some minimal superior and inferior erosive osteolysis with metal debris present.There was also a mention of periprosthetic osteolysis of internal prosthetic right hip joint, sequela metallosis.Doi: (b)(6) 2008; dor: (b)(6) 2018 (right hip).

Manufacturer Narrative

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.

• 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: 9776456
• MDR Text Key: 189304519
• Report Number: 1818910-2020-06559
• 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: 10/15/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 80