MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*CUP SUPERCUP,L32,51DP; HIP ACETABULAR CUP

Catalog Number 552051

Device Problem Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Date 11/20/2017

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.

Event Description

The patient was revised to address pain.It was noted on x-ray that there was bone loss in the acetabulum.A revision was performed to remove the loose acetabular component.Doi: (b)(6) 1993; dor: (b)(6) 2017; unknown hip.Revision acetabular component for total hip replacement, (b)(6), (b)(6), (b)(6) 2017.Primary implant date: (b)(6) 1993.Patient presented to surgeon with hip pain.On x-ray evaluation it was noted that there was bone loss in the acetabulum.A acetabular revision was performed to remove the loose acetabular component and revise to revision cup and cemented liner.Pre op x-rays available, no other documentation available.Male patient initials: (b)(6), aged (b)(6), dob: (b)(6).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork MA ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7120614
• MDR Text Key: 94944183
• Report Number: 1818910-2017-51741
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

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: 552051
• Device Lot Number: S0256-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 08/16/2018
• 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
• Patient Age: 76 YR