MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-806

Device Problem Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Chronology of events: (b)(6) 2020 primary knee implantation, attune ps postoperative complications: anterior knee pain in standing position; knee noise during movement; periodic swelling associated with knee pain and limited rom.(b)(6) 2020 revision knee surgery intraoperative finding: soft tissue fibrosis with suspected to low grade infection; soft tissue reduction, pulse lavage, soft tissue rebalancing and ps insert replacement, femoral and tibial components intact.Implant removed: : ref: 1516-40-806, lot j03u45; current status: cleaned and decontaminated.Implant implanted: ref:1516-40-808, lot: hc8950 (label attached).Post-revision current state: low grade infection status - negative (microbiological trials with several tissue samples) patient still feels discomfort in motion and periodic anterior knee pain.Conciliar decision: rehabilitation with patient monitoring; reintervention by arthroscopic method: lateral retinacular release and reduction of the patellar ridge.

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.Corrected: h6 (clinical code).The code for infection is now being retracted as per additional information received, infection was not proven.

Event Description

Additional information received indicated that there was no proven infection and the infection status was negative.The reason for implant insertion was soft tissue rebalancing and ps insert replacement.Surgery time was not extended.

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 : 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FB INSRT SZ 8 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11737621
• MDR Text Key: 247707635
• Report Number: 1818910-2021-09031
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295050353
• UDI-Public: 10603295050353
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1516-40-806
• Device Catalogue Number: 151640806
• Device Lot Number: J03U45
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 05/12/2021; 07/01/2021
• Supplement Dates FDA Received: 05/26/2021; 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 7 CEM.; ATTUNE PS FB INSRT SZ 8 6MM.; ATTUNE PS FEM LT SZ 8 CEM.; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE PS FB INSRT SZ 8 6MM; ATTUNE PS FEM LT SZ 8 CEM
• Patient Outcome(s): Required Intervention