MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 9 8MM; KNEE TIBIAL INSERT

Model Number	1517-10-908
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/30/2020
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
It was reported that the patient had a left primary tka with revision parts.At time of poly insertion, extreme difficulty was had reducing the poly & femoral interface.Many attempts were made to reduce construct.There was a surgical delay of 20 mins.Doe: (b)(6) 2020, left knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Removed code for device revision or replacement and replaced with no code available (3191) for prolonged surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Correct: h6 patient code: no code available (3191) used to capture the device revision or replacement and insufficient information.

• Brand Name: ATTUNE CRS RP INSRT SZ 9 8MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10264294
• Report Number: 1818910-2020-15635
• Device Sequence Number: 14107784
• Product Code: NJL
• UDI-Device Identifier: 10603295056355
• UDI-Public: 10603295056355
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2020

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: 1517-10-908
• Device Catalogue Number: 151710908
• Device Lot Number: 9211531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020; 08/11/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 07/13/2020; 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK ATTUNE FEMORAL; UNK ATTUNE FEMORAL
• Patient Age: 66 YR