MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. HP MBT NONCEM PUNCH SZ4-7; KNEE INSTRUMENT/TRIAL

Catalog Number 950502021

Device Problem Incorrect Measurement (1383)

Patient Problem No Information (3190)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this 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 trial is about 2mm too long in direction to joint.It is possible to assemble it to the trial inlay, but this is located about 2 mm above the tibial base.This simulates a joint line more narrow than actually existing.

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

Conclusion and justification status for mdr: the investigation confirmed the reported event.The root cause is product design.Capa-(b)(4) has been initiated to further investigate and identify corrective actions.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: HP MBT NONCEM PUNCH SZ4-7
• Type of Device: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5352999
• MDR Text Key: 35350423
• Report Number: 1818910-2016-10317
• Device Sequence Number: 1
• Product Code: LRY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950502021
• Device Lot Number: ABB39952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1