MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 4 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-50-412

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

Patient Problem Unspecified Infection (1930)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: 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.Clinical notification update ((b)4) clinical update ad 29 mar 2022) reviewed, along with the current clinical database.The diagnosis as written in the clinical database adverse event log entry is "aspiration of study knee - as a result of raised crp and infection - confirmation of loosening tibial component".This indicates that the infection has been confirmed.There has yet to be any reported knee revision, so the tibial tray loosening remains unconfirmed.Therefore, impacted products, and patient coding will be updated to address this new information.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 aspiration of study knee (right) - confirmation of loosening tibial component.Event is serious and is considered severe.Event is possibly related to device and is probably related to procedure.Date of implantation: (b)(6) 2018, date of event (onset): (b)(6) 2021, (right knee).Treatment: aspiration of knee.

Event Description

Additional information was received indicating that the "bone cement has leaked from beneath the tray onto the sleeve during insertion / pressurization which prevented biological ingrowth.".

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this complaint was received for investigation.Visual examination of the returned device found nothing indicative of a device nonconformance.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.

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE PS RP INSRT SZ 4 12MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14073466
• MDR Text Key: 288989376
• Report Number: 1818910-2022-06467
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052333
• UDI-Public: 10603295052333
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2022

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 Model Number: 1516-50-412
• Device Catalogue Number: 151650412
• Device Lot Number: 8126949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 05/12/2022; 07/11/2022; 07/18/2022
• Supplement Dates FDA Received: 05/19/2022; 07/13/2022; 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE CEMENTED STEM 16X80MM.; ATTUNE CRS FEMORAL RT SZ 4 CEM.; ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE POS FEM AUG SZ 4 4MM.; ATTUNE PS RP INSRT SZ 4 12MM.; ATUN TIB SLV M/L 29MM HALF POR.; ATUNE REV RP TIB BASE SZ 4 CEM.; PALACOS R+G 2X40 CAT.NO.66017569 LOT 88664782.; PALACOS R+G 2X40 CAT.NO.66017569 LOT 88664782.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 89 KG