MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS RP INSRT SZ7 5MM; KNEE TIBIAL BEARING/INSERT

Catalog Number 150610005

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 10/29/2015

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Surgeon suspected that the attune tibial baseplate was loose intra-operatively after cementing component during a primary tka.While patient was still in surgery for her primary attune tka, surgeon removed and replaced attune rp baseplate, attune ps rp poly liner and zimmer bone cement from the tibia bone.Surgeon believes the anterior lip of the baseplate "popped up" while cement was hardening- likely from pressures from the posterior femoral condyles.When the baseplate was removed from the patient there was no bone cement fixation to the backside surface.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the provided product and lot combination.(b)(4) has been undertaken to investigate further.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.

• Brand Name: ATTUNE PS RP INSRT SZ7 5MM
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5225180
• MDR Text Key: 31253388
• Report Number: 1818910-2015-35106
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150610005
• Device Lot Number: 8116082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2015
• 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: 63 YR