MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 20MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151640720

Device Problems Fitting Problem (2183); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

(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

Der states for hemarthrosis of knee; surgeon questioned whether joint was infected.Cultures sent in but still awaiting results as of 15:00 on (b)(6) 2017.Femoral component suspected to be loose.Surgeon explanted femur, poly and tray revising with attune revision system.It was also reported that the femur was loose at the bone/cement interface.Competitor cement was used.Additionally, surgeon was unable to seat final poly insert.The posterior aspect of the poly sat flush with the tray but felt that anterior aspect never seated.He requested the product be sent back to investigate.Doi: (b)(6) 2017 dor: (b)(6) 2017 right knee surgical delay of 6 minutes.

Manufacturer Narrative

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

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: evaluation of the returned device confirms the reported event.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.Device history lot
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> product code 151640720, lot number 517965 device history review
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> dhr reviewed no related nonconformances that would have contributed to the reported event.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FB INSRT SZ 7 20MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7163639
• MDR Text Key: 96353534
• Report Number: 1818910-2018-50168
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050292
• UDI-Public: 10603295050292
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151640720
• Device Lot Number: 517965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 12/19/2017; 03/08/2018
• Supplement Dates FDA Received: 01/08/2018; 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• 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: 69 YR