MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 4 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-30-406

Device Problems Disassembly (1168); Device Dislodged or Dislocated (2923)

Patient Problems Tissue Damage (2104); Not Applicable (3189); No Code Available (3191)

Event Date 02/27/2018

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

Received medical records on 05/18/2018.Patient has bilateral attune total knees.Right knee was revised to address instability and suspected tibial component loosening.Intraoperatively, the revising surgeon stated, "it was noted that the medial side of the knee was quite lax and there was no stability on that side.Because of this, the polyethylene insert was coming loose from the tibial component and was not totally loose, but was shifting and the knee was totally unstable." the surgeon determined that the tibial base plate component was not loose, nor was the femur component.A thicker polyethylene insert was implanted.The patient was placed in a hinged knee brace post-operatively.Femur, tibial tray, and patella components were left unrevised.Post-op diagnosis was medial collateral ligament tear and loose tibial insert component--there was no suggestion that products contributed to the ligament injury.Doi: (b)(6) 2016; dor: (b)(6) 2018; (right knee).

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.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 will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 patient code: no code available (3191) was used to capture joint instability and device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Patient received a right primary attune tka to treat osteoarthritis.The patella was resurfaced and depuy cement x 1 was utilized.The procedure was completed without complications.Doi: (b)(6) 2016; dor: (b)(6) 2018; (right knee).This complaint needs to be linked to (b)(4), which captures the revision of the 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 at this time.Should additional information be received, the information will be reviewed and the investigation may 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.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 unrelated 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.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.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.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CR RP INSRT SZ 4 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7604650
• MDR Text Key: 111141152
• Report Number: 1818910-2018-62254
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295047636
• UDI-Public: 10603295047636
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 1516-30-406
• Device Catalogue Number: 151630406
• Device Lot Number: 8129881
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM RT SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR