MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 8 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-805
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
After placing the definitive rotating polyethylene of the tibia, it proved to be unstable in rotation, making a spin out movement in the knee flexion.It was tested before and it did not happen in the test with the proof poly so we had to open a second polyethylene of a higher number.Initially 5 and then the final 6.Intraoperatively, after all proof tests, the item sku (b)(4) (8x5 mm) was opened, after opening and implanting it, the doctor was not satisfied with the flexion extension and ligament balance, choosing to open another 8x6 mm insert (b)(4) (medical decision).In which he is the only one in the surgical moment that he can evaluate and he reported this in his justification to the hospital.There was no harm to the patient's health.
Additional 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.Device history lot : no device associated with this report was received for examination.A review of the device manufacturing records (dhr) was performed.Product code 151630805 work order (b)(4) was manufactured on 30-march-2017.(b)(4) parts were manufactured per specification and all raw materials met specification.1 scrap part associated with this lot.1 part scrapped for black spot/imbedded particle.This scrap code has no correlation with the complaint failure mode.No reprocessing associated with this lot.1 nonconformance associated with this lot.Nr-(b)(4) relates to parts machined over tolerance for surface finish.All affected parts were reworked into specification.As a result, there is no correlation between nr-(b)(4) and the complaint failure mode.A full review of the dhr and oms history was completed for lot 8490460.There was no in process deviations found that could be linked to the complaint failure mode while the parts were being manufactured.Therefore, this complaint was deemed non-verifiable through the device history record review.No further action is required.

• Brand Name: ATTUNE CR RP INSRT SZ 8 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12218745
• Report Number: 1818910-2021-15897
• Device Sequence Number: 4062495
• Product Code: NJL
• UDI-Device Identifier: 10603295048107
• UDI-Public: 10603295048107
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1516-30-805
• Device Catalogue Number: 151630805
• Device Lot Number: 8490460
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR