MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE RP TIB BASE SZ 8 CEM; KNEE TIBIAL TRAY

Model Number 1506-10-008

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 06/19/2017

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.

Event Description

The patient was revised to address pain, stiffness, and loosening of the tibial tray at the cement to implant interface.Depuy cement was used.Doctor thought it was best to go up a size in the poly, based on trailing after he re-implanted.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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.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
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> no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.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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> (b)(4) were manufactured per specification and all raw materials met specification.1 scrap part associated with this lot.This scrap failure mode has no correlation with the complaint failure mode.No reprocessing associated with this lot.No deviations found.

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.  h6 (no code available (3191) is used to capture the surgical intervention and medical device removal).These information have been reported in (b)(4) with an mfr number 1818910-2019-109361.Mfr number 1818910-2019-109361 has been retracted due to a duplicate of this mfr number 1818910201721182.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Event Description

Medical records received 17 june 2019 and were reviewed 17 september 2019 for mdr reportability.On (b)(6) 2016, the patient underwent total left knee arthroplasty due to bilateral knee osteoarthritis and pain.It was noted the patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 2.On (b)(6) 2017, the patient underwent a left knee revision due to pain and discomfort.The surgeon indicated the tibial component was loose at the implant to cement interface.He noted the femoral component appeared to be solid and was not revised, and the patella was stable and not revised.The patient was implanted with attune system and smartset cement x 2 and there were no complications to the procedure.Doi: (b)(6) 2016, dor: (b)(6) 2017 (lt knee).

• Brand Name: ATTUNE RP TIB BASE SZ 8 CEM
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 6713537
• MDR Text Key: 80031337
• Report Number: 1818910-2017-21182
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042624
• UDI-Public: 10603295042624
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1506-10-008
• Device Catalogue Number: 150610008
• Device Lot Number: 8294091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 7 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR