MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE SHIM SZ9 5MM; KNEE INSTRUMENT/TRIAL

Catalog Number 254500691

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/24/2016

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

Metal location ring has come out of shim.

Manufacturer Narrative

The device associated with this report was not returned.Follow up communication for product return was unsuccessful.A (b)(4) (preliminary risk assessment) meeting was held to discuss a product escalation out of (b)(4) concerning the attune shims.The team has determined that there is no additional patient risk associated with this issue.Although cracks are occurring, this failure mode does not lead to a patient harm of infection.The rate of infection for attune is within the state rate in the risk management report and is statistically similar to the rate of infection for the total knee class.Previous investigations found although a definitive root cause is not known, a combination user technique, improper technique or misuse, and the use of contraindicated chemicals (non-compliant to cleaning guidelines), may lead to weakening of the material.Based on the performed investigation and (b)(4) determination of no additional patient risk, corrective action is not indicated.Continue to monitor via sep-419.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

The investigation has been reopened because product has been received.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

Conclusion and justification status for mdr: examination of the returned attune shim sz9 5mm confirms the bushing component has migrated out of the bushing hole.A pra (b)(4) meeting was held to discuss a product escalation out of (b)(6) concerning the attune shims.The team has determined that there is no additional patient risk associated with this issue.Although cracks are occurring, this failure mode does not lead to a patient harm of infection.The rate of infection for attune is within the state rate in the risk management report and is statistically similar to the rate of infection for the total knee class.Previous investigations found although a definitive root cause is not known, a combination user technique, improper technique or misuse, and the use of contraindicated chemicals (non-compliant to cleaning guidelines), may lead to weakening of the material.Based on the performed investigation and (b)(4) determination of no additional patient risk, corrective action is not indicated.Continue to monitor via (b)(4).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: ATTUNE SHIM SZ9 5MM
• 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: 5573758
• MDR Text Key: 42540228
• Report Number: 1818910-2016-17298
• Device Sequence Number: 1
• Product Code: HWT
• 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,Followup
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254500691
• Device Lot Number: BFA0WMF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2014
• 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