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

Catalog Number	157005090
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• MDR Report Key: 7548660
• Report Number: 1818910-2018-60675
• Device Sequence Number: 13507284
• Product Code: LWJ
• UDI-Device Identifier: 10603295059691
• UDI-Public: 10603295059691
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K030122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 157005090
• Device Lot Number: D16012332
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR