MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ6 HI; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157013120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	05/16/2019
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
Subject id: (b)(6).Clinical adverse event received for dvts bilaterally: vascular - dvt.Event is serious and is considered moderate.Event is definitely not related to device and possibly related to procedure.Doi: (b)(6) 2019; dor: (b)(6) 2019 ,(pelvic fracture: cup, liner, and head revised); doe: (b)(6) 2019, (right hip).Depuy hip components present at the time of the ae: catalog id: 101185000, lot: 348034, description: protrusio cage 48mm x 45mm rt; catalog id: 122132048, lot: j19u80, description: pinnacle altrx polyethylene acetabular liner neutral 32mm id 48mm od; catalog id: 136521000, lot: d18122792, description: articul/eze head cocr 32mm +1; catalog id: 545032500, lot: 8719593, description: depuy cmw 2 gentamicin bone cement ; catalog id: 545032500, lot: 8939042, description: depuy cmw 2 gentamicin bone cement ; catalog id: 3322020, lot: 8885300, description: smart set bone cement 20g; catalog id: 101140020, lot: j30c19, description: self tapping screw 20mm; catalog id: 101140020, lot: j30c19, description: self tapping screw 20mm; catalog id: 101140015, lot: 371070, description: roof pile screw 15mm; catalog id: 101140025, lot: hd7680, description: roof pile screw 25mm; catalog id: 101140030, lot: j30c36, description: roof pile screw 30mm; catalog id: 101140025, lot: j09t28, description: roof pile screw 25mm; catalog id: 101140030, lot: j30c37, description: roof pile screw 30mm; catalog id: 101140015, lot: h59257, description: roof pile screw 15mm; catalog id: 137622000, lot: j1524p, description: cementralizer distal 13.0mm; catalog id: 157013120, lot: d19021860, description: summit stem cemented high offset sz 6 12/14 taper; catalog id: 3312040, lot: 8708235, description: smart set cmw 1 40g; catalog id: 3312040, lot: 8708235, description: smart set cmw 1 40g.
Additional 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.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.

• Brand Name: SUMMIT CEMENTED STEM SZ6 HI
• 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: 8682610
• Report Number: 1818910-2019-95569
• Device Sequence Number: 2309156
• Product Code: JDI
• UDI-Device Identifier: 10603295060253
• UDI-Public: 10603295060253
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K013352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 157013120
• Device Lot Number: D19021860
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/18/2019
• 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: 72 YR
• Patient Weight: 61