MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 49MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

Catalog Number 136349000

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address pain.It was stated that patient originally had hemi hip and converted to total hip.Doi: unknown; dor: (b)(6) 2018; right hip.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MODULAR CATHCART BALL 49MM OD
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7471862
• MDR Text Key: 106844448
• Report Number: 1818910-2018-58451
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032816
• UDI-Public: 10603295032816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136349000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• 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: 75 YR