MAUDE Adverse Event Report: DEPUY-RAYNHAM, DIV OF DEPUY ORTHO ¿ REG# 1219655 SROM NRHFEM W/PIN SM RT 66X62; KNEE FEMORAL COMPONENT

Catalog Number 623411R

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 02/28/2017

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

The proximal peg broke off after about 5 years implantation time.Patient weight about (b)(6).Without trauma while walking suddenly pain and instability in the right knee joint.During revision, a fracture of taper connection was obvious.

Manufacturer Narrative

No device associated with this report was received for examination.Review of provided photographs confirm the reported breakage.Review of the device history records did not reveal any manufacturing deviations or anomalies.The investigation could not draw any conclusions about the root cause of the device fracture based on the provided information.No evidence was found indicating product error was a contributing factor to the device fracture and the need for corrective action is not indicated.Depuy considers the investigation closed.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: SROM NRHFEM W/PIN SM RT 66X62
• 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: 6420182
• MDR Text Key: 70411497
• Report Number: 1818910-2017-15048
• 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
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 623411R
• Device Lot Number: EN7JD4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2010
• 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 Weight: 170