MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CRS RP INSRT SZ 5 6MM; KNEE TIBIAL INSERT

Catalog Number 151710506

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 12/08/2018

Event Type  Injury  

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

Clinical adverse event received for infection.

Manufacturer Narrative

No device associated with this report was received for examination.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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.We received a clinical adverse event for infection.Event is serious can considered severe.Event is possibly related to device and definitely related to procedure.Doi: on (b)(6) 2018; doe: on (b)(6) 2018; dor:on (b)(6) 2018; right knee.Treatment includes irrigation and debridement, medication injection and revision of the tibial insert.No device associated with this report was received for examination.None of the information provided confirms the report.A dhr review was conducted by the manufacturing site: product code 151710506, work order (b)(4) was manufactured on 24-may-2018.(b)(4) parts were manufactured per specification and all raw materials met specification.Product code 151710506, work order (b)(4) of quantity (b)(4) was sterilized on (b)(6) 2018 per the sterilization certificate; the sterilization cycle met the validated parameters.One non-conformance, nr-0103557, is associated with this lot, however there is no correlation with the failure mode.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional reports against the provided product code/lot code combination (151710506/8813961).Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specification at the time it was released for distribution.  the device associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.Overall, from the event information received, it was not possible to determine the relationship of the device to the reported event.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.

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.Additional narrative: no code available (3191) used to capture medical device removal.

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.No code available (3191) used to capture wound secretion.

• Brand Name: ATTUNE CRS RP INSRT SZ 5 6MM
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8270502
• MDR Text Key: 133850906
• Report Number: 1818910-2019-81957
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295055907
• UDI-Public: 10603295055907
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 151710506
• Device Lot Number: 8813961
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 81