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

Model Number 1516-40-808

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

Patient Problems Pain (1994); Discomfort (2330)

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

(b)(6) 2020 revision knee surgery.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.

Event Description

A.Was surgery time extended? if yes, what was the duration of the delay? answer: no, the operation time has not been extended.B.Please confirm if the cement was manufactured by depuy? if yes, please provide the quantity, part and lot numbers of the cement.Answer: smartset gmv endurance, 40 gr: ref: (b)(4); lot: 9102841.Image attached.Radiographs/x-ray films please provide all x-rays relevant to the reported event for example - pre-operative, post primary, pre-revision and intervening time points.- x ray images attached.Patient demographics the following are the types of patient demographics we require: relevant comorbidities.- n/a.Patient records can¿t be accessed for privacy reasons.The verbally obtained information is that the patient does not have pronounced comorbidities that would affect postoperative recovery.

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: added: b5 and d10.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: 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 8MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11750269
• MDR Text Key: 248163256
• Report Number: 1818910-2021-09246
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295050377
• UDI-Public: 10603295050377
• 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

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 1516-40-808
• Device Catalogue Number: 151640808
• Device Lot Number: HC8950
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 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 FEM LT SZ 8 CEM; SMARTSETGMV ENDURANCE GENT 40G
• Patient Outcome(s): Required Intervention