MAUDE Adverse Event Report: 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC CEMENT RESTRICTOR SIZE 1; CEMENT/CEMENT ACCESSORY

Catalog Number 546010000

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 09/22/2016

Event Type  Injury  

Manufacturer Narrative

Udi: (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

The patient's medical records were received.Medical records indicate the patient was revised to address anterior subluxations and what was thought to be an early onset of infection.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) 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.Corrective action was not indicated.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.

• Brand Name: CEMENT RESTRICTOR SIZE 1
• Type of Device: CEMENT/CEMENT ACCESSORY
• Manufacturer (Section D): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6080912
• MDR Text Key: 59282124
• Report Number: 1818910-2016-30925
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 546010000
• Device Lot Number: 614852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/14/2015
• 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: 61 YR
• Patient Weight: 79