MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM STM STD 36+12L 15X20; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 563620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hematoma (1884); Pain (1994)

Event Date 02/21/2019

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

Subject id: (b)(6).Clinical adverse event received for greater trochanteric femoral bone fracture.Event is not serious and is considered moderate.Event is probably related to device and definitely not related to procedure.Doi: (b)(6) 2014.Doe: (b)(6) 2019.(left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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.

Manufacturer Narrative

Product complaint # (b)(4).

• Brand Name: SROM STM STD 36+12L 15X20
• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8455164
• MDR Text Key: 139959926
• Report Number: 1818910-2019-88557
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295178231
• UDI-Public: 10603295178231
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2019

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: 563620
• Device Lot Number: 8020276
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 03/07/2019; 03/22/2019; 04/12/2019
• Supplement Dates FDA Received: 03/27/2019; 04/09/2019; 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 95