MAUDE Adverse Event Report: DEPUY IRELAND 9616671 AMK TIB INS SIZE 3 12MM; KNEE TIBIAL BEARING/INSERT

Catalog Number 148852025

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 10/07/2014

Event Type  Injury  

Event Description

Patient was revised to address stress shielding.Update rec¿d (b)(6) 2014 - patient's medical records were received.Medical records were reviewed for mdr reportability.Records indicate upon revision the patient's tibial tray had mechanically loosened and the insert was found to be worn.The patient's tibial insert, tray, and cement are being reported at this time.The complaint was updated on: (b)(6) 2014.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Manufacturer Narrative

The device associated with this report was not returned.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.Patient medical records and x-rays were received and reviewed by a depuy medical professional.Loosening of the tibial device and polyethylene wear was confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for 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: AMK TIB INS SIZE 3 12MM
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4293796
• MDR Text Key: 16177842
• Report Number: 1818910-2014-33185
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 148852025
• Device Lot Number: XD1EB1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2003
• 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 Age: 68 YR