MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FB INSRT SZ 9 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151640906

Device Problems Difficult to Insert (1316); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

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

Atunne femoral component 9 and tibia component 7 were used, when they tried to implant the attune insert size 9/6mm the insert did not sit on the tibial plato, and appeared to have an overhang and the knee could not function properly.They then used the attune insert 9/5mm which fit perfectly with no problem.

Manufacturer Narrative

(b)(4).Investigation summary:no device was returned.Depuy synthes considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: the device was reviewed by the manufacturing site and concluded that the issue was not manufacturing related.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary
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> the device was reviewed by the manufacturing site and concluded that the issue was not manufacturing related root cause undetermined depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The device was reviewed by the manufacturing site raynham and a report was received stating; manufacturing review of the dhr associated with the manufacturing of p/n 151640906 (batch c54654) along with physical examination of the part identified that the issue was not manufacturing related.The returned part was evaluated by quality engineering and process engineering and damage was observed on the inferior face of the part.The inferior snap tab is protruding in the z direction due to its placement, and subsequent removal, from the tibial plateau as the surgeons swapped this attune insert 9/6mm with an attune insert 9/5mm.The protrusion of the tab makes dimensional confirmation testing impossible because the flat face of the inferior side of the insert cannot be used as a reliable basis of coordination by the cmm.Dimensional confirmation testing would not be representative of the actual dimensions of this part, so cmm verification would lead to undue alarm.Dhr review: the dhr showed that all 12 parts in batch c54654 passed cmm inspection and provided a sample of cmm dimension measurements used in the acceptance process.In process control: there is a 100% verification of all ctqs for 100% of products in a batch.A worldwide complaint search was conducted for complaints related to product # 151640906.The list was reviewed for instances of dimensionally nonconforming attune inserts.The review returned no instance of this no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per (b)(4).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 9 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8070756
• MDR Text Key: 127137394
• Report Number: 1818910-2018-75497
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050490
• UDI-Public: 10603295050490
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151640906
• Device Lot Number: C54654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1