MAUDE Adverse Event Report: 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC ATTUNE PS FB INSRT SZ 3 5MM; KNEE TIBIAL BEARING/INSERT

Catalog Number 151640305

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 03/04/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Conclusion and justification status for mdr: examination of the submitted insert revealed damage consistent with unsuccessful attempts to seat the insert in a tibial baseplate.Markings on the insert indicate that it was not fully seated posteriorly before being impacted for locking.Review of the device history records did not reveal any manufacturing deviations or anomalies.No evidence was found suggesting product error was a contributing factor and 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.(b)(4).

Event Description

Attune insert deformation in surgery.As the surgeon could not fix the attune insert properly, the impaction was repeated.At that time, the insert was finally deformed.Another product was used to complete the case.The surgery was delayed about 10 minutes.There was no adverse consequences to the patient.

• Brand Name: ATTUNE PS FB INSRT SZ 3 5MM
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 5260422
• MDR Text Key: 32476575
• Report Number: 1818910-2015-32677
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 151640305
• Device Lot Number: 290799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2012
• 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