MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 SUMMIT BASIC PRESS FIT SZ 3; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157005090

Device Problem Insufficient Information (3190)

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

Event Date 04/30/2018

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

Der states that the patient's hip was converted from hemi to a total due to pain.Summit basic stem and bipolar head were explanted, and an aml stem, cup, liner and head were implanted.Doi: (b)(6) 2016; dor: (b)(6) 2018; unknown hip.No surgical delay.

Manufacturer Narrative

Product complaint # : (b)(4).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: SUMMIT BASIC PRESS FIT SZ 3
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7548660
• MDR Text Key: 109375737
• Report Number: 1818910-2018-60675
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295059691
• UDI-Public: 10603295059691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030122
• 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: 04/30/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 157005090
• Device Lot Number: D16012332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 06/26/2018
• Date Device Manufactured: 02/02/2016
• 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: 85 YR