MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT

Catalog Number 545032500

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

Patient Problem Thrombosis (2100)

Event Date 05/16/2019

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

(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.

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: DEPUY/CMW 2G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw 46582
• Manufacturer (Section G): CMW MFG & MATERIAL WAREHOUSE; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8682600
• MDR Text Key: 147455064
• Report Number: 1818910-2019-95567
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174271
• UDI-Public: 10603295174271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 545032500
• Device Lot Number: 8939042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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: 72 YR
• Patient Weight: 61