MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 4 CEM; KNEE TIBIAL TRAY

Catalog Number 150610004

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395)

Patient Problems Not Applicable (3189); No Information (3190)

Event Date 05/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

Patient was revised to address subsidence and loosening.Loosening occurred at the cement to implant interface.Cement manufacturer is unknown.

Manufacturer Narrative

No device associated with this report was received for examination.A complaint database search on the provided attune rp tib base sz 4 cem (product code 150610004, lot number 8000614) found an additional report and a dhr review was conducted.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the reported product and lot combination.(b)(4) has been undertaken to investigate attune post operative loosening further.Corrective action was not indicated.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.

Manufacturer Narrative

Product complaint : (b)(4).

Event Description

Patient was revised to address subsidence and loosening.Loosening occurred at the cement to implant interface.Cement manufacturer is unknown.Doi (b)(6) - dor (b)(6) 2016 (left knee).

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot dhr review.Product code 150610004, work order (b)(4) was manufactured on 09 oct 2014, 20 parts were manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this lot.Due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.Root cause category: undetermined: insufficient information.Root cause determination: as the complaint has not been verified, it is not possible to establish a root cause.Corrective action/ follow-up: as the complaint has been deemed non-verifiable, it is not possible to establish corrective action.Complaint confirmed?: non-verifiable.Corrective action type: c/a not taken.See attachment; memo 2016-410 review of lot 8000614, attune rp tib base sz 4 cem for comact- 372137.

• Brand Name: ATTUNE RP TIB BASE SZ 4 CEM
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 5721153
• MDR Text Key: 47284214
• Report Number: 1818910-2016-21201
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• PMA/PMN Number: PP830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150610004
• Device Lot Number: 8000614
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/13/2016
• Supplement Dates Manufacturer Received: Not provided; 06/29/2018; 07/21/2020
• Supplement Dates FDA Received: 07/21/2016; 06/29/2018; 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR