MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ4 STD; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157003100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/03/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Complaint description: clinical der states that patient experienced femoral loosening, noted to be related to an intraop cement mantle fracture.Event does not meet the definition of serious and is considered mild.Event is not related to device and is related to procedure./ | investigation method: medical records reviewed ((b)(6) 2017) - (ch) from a medical perspective, based on the information available, it is not possible to determine if the complaint is product related.
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 CEMENTED STEM SZ4 STD
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7298863
• Report Number: 1818910-2018-54143
• Device Sequence Number: 11075116
• Product Code: JDI
• UDI-Device Identifier: 10603295059547
• UDI-Public: 10603295059547
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K013352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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 Catalogue Number: 157003100
• Device Lot Number: D12112600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 04/20/2018
• 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: 65 YR
• Patient Weight: 64