MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FB INSRT SZ 5 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-512
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The patient was revised to address insert dissociation and migration into the suprapatellar space.Doi: (b)(6) 2017; dor: (b)(6) 2018; right side.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: product code 151620512, lot number 578870 device history review : dhr reviewed - no deviations or nonconformances were noted.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Udi: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: update (b)(6) 2021: the investigation was re-opened upon receipt of additional information.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: product code 151620512, lot number 578870.Device history review: dhr reviewed - no deviations or nonconformances were noted.H10 additional narrative: added: h6 (clinical and impact codes).H6 clinical code: appropriate term / code not available (e2402) is used to capture injury (e20).Corrected: g1.

• Brand Name: ATTUNE CR FB INSRT SZ 5 12MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7517814
• Report Number: 1818910-2018-59696
• Device Sequence Number: 16435266
• Product Code: JWH
• UDI-Device Identifier: 10603295045694
• UDI-Public: 10603295045694
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 1516-20-512
• Device Catalogue Number: 151620512
• Device Lot Number: 578870
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 11/26/2019; 01/21/2021
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 08/30/2018; 11/28/2019; 01/22/2021
• 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: ATTUNE CR FEM RT SZ 5 NAR CEM.; ATTUNE MEDIAL DOME PAT 35MM.; COMPETITOR'S BONE CEMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR