MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150600005

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Attune knee prosthesis revision surgery on patient.The patient had been experiencing severe pain in his knee operated with a primary prosthesis.At the time of the revision surgery, the doctor makes an incision where he does not find any visible signs of infection, but in any case he takes culture samples, and it is found that the problem was presented by the primary tibial plate that was loosened, which left completely without cement adhered to the implant.The area of the tibial plateau was the bone with all of the inter fingering cement making it difficult to extract it and the femoral component was completely adhered to the bone no problems presented.Current status of the patient: he is hospitalized post-operated prosthesis attune review.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> no device associated with this report was received for examination.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.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

Product complaint #: (b)(4).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.  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).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.Investigation summary: the received device was forwarded to commercialized product development for evaluation.Review of the received device confirmed 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.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.Monitor: exempt per wi-7915 - known possible complication of joint replacement surgery.No device associated with this report was received for examination.One photograph of the reported revised device was provided for review.The photograph shows the complaint subject tibial base plate and tibial insert removed at revision surgery.Tibial baseplate: the view of the tibial baseplate is of the fixation side.There is no visible adhered bone cement.Tibial insert: no visual anomalies were identified.The reported tibial tray loosening could not be confirmed based on the review of the photograph.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 related reports against the provided product code/lot code combination.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.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 was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified.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.16-oct-2019: device received.The complaint sample consisted of (1) 150600005 attune fb tib base sz 5 cem, lot number 8356190 the received device was forwarded to commercialized product development for evaluation.Tibial tray exhibited scratches attributed to extraction.Tibial tray was devoid of cement and slight burnishing was noted on the fixation surface of the tibial tray, which is indicative of micromotion between the cement/implant interface.A definitive root case of the reported event is unknown.For addition information relevant to the evaluation and observations of the returned product, see full report attached under product development investigation.The root cause of the device micromotion/loosening is unknown.No evidence was found indicating product error was a contributing factor to the device loosening and this investigation did not establish a need for corrective action.Complaint trends will be monitored by post market surveillance through sep-419.No new 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.Device history lot: null.Device history batch: null.Device history review: null.

• Brand Name: ATTUNE FB TIB BASE SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8379330
• MDR Text Key: 137447585
• Report Number: 1818910-2019-86082
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042396
• UDI-Public: 10603295042396
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150600005
• Device Lot Number: 8356190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention