MAUDE Adverse Event Report: DEPUY CMW¿ 9610921 CEMENT RESTRICTOR SIZE 4; CEMENT / CEMENT ACCESSORY

Catalog Number 546016000

Device Problems Disassembly (1168); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address loosening of the stem.Loosening occured at implant to cement interface.Depuy cement was used.

Manufacturer Narrative

The patient was revised to address loosening of the stem.Loosening occured at implant to cement interface.Depuy cement was used.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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: CEMENT RESTRICTOR SIZE 4
• Type of Device: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY CMW¿ 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW¿ 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6846244
• MDR Text Key: 85019734
• Report Number: 1818910-2017-24131
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295174356
• UDI-Public: 10603295174356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 546016000
• Device Lot Number: 694313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2015
• 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: 80 YR