MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MODULAR CATHCART BALL 43MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

Catalog Number 136343000

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Not Applicable (3189)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Patient was revised to address deep infection.Patient had hemi hip on (b)(6) 2018.This was case number (b)(4) through performance ortho.Surgeon took her to the operating room an did an i&d and head exchange doi: (b)(6) 2018.Dor: (b)(6) 2018.Left hip.

Manufacturer Narrative

Product complaint #: (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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: MODULAR CATHCART BALL 43MM OD
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0998
• Manufacturer (Section G): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0998 ; 5743725905
• MDR Report Key: 7893131
• MDR Text Key: 120833090
• Report Number: 1818910-2018-69858
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032755
• UDI-Public: 10603295032755
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136343000
• Device Lot Number: D17101940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2017
• 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: 81 YR
• Patient Weight: 70