MAUDE Adverse Event Report: DEPUY-RAYNHAM, DIV OF DEPUY ORTHO ¿ REG# 1219655 SROM NRHFEM W/PIN MED RT 71X66; KNEE FEMORAL COMPONENT

Catalog Number 623401R

Device Problem Break (1069)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); No Information (3190)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(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

Patient was revised to address the breakage of the stem that is part of the femoral component.

Manufacturer Narrative

This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

The reported fractured device associated with this report was not returned.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.A complaint database search finds no additional reports against the product and lot combination.Review of the device history records did not reveal any manufacturing deviations or anomalies.The investigation could not draw any conclusions about the reported fractured device based on the lack of the device to examine and insufficient information.Based on the inability to determine a root cause, a need for corrective action is 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: SROM NRHFEM W/PIN MED RT 71X66
• Type of Device: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY-RAYNHAM, DIV OF DEPUY ORTHO ¿ REG# 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY-RAYNHAM, DIV OF DEPUY ORTHO ¿ REG# 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5778196
• MDR Text Key: 49030977
• Report Number: 1818910-2016-22776
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 623401R
• Device Lot Number: 265715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2012
• 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: 65 YR