MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ4 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Joint Laxity (4526)
Date of Event	12/31/2020
Type of Reportable Event	Serious Injury
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
The patient was revised due to fall 6 months after the primary surgery.Needed more stability/constraint on the poly insert.Converted to a crs femur and insert.Rp rev tray was used in the primary case due to high bmi so did not have to change it.Doi: (b)(6) 2020, dor: (b)(6) 2020, right knee.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Additional 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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
1.Please confirm if there was any indication that the patient's knee was unstable prior to the revision surgery? answer: no indication of instability prior to fall.2.Was there any adverse consequences due to fall? answer: the knee became unstable after the fall so have to assume it was from the fall.3.Was there a previous revision involving explanation of depuy products? answer: no previous revision.4.Was instability related to polyethylene wear? answer: not related to poly wear.Poly looked good.5.Was there any reported malposition of components that led to the instability? answer: no malpositioning.6.Were any components undersized on the primary surgery that led to the instability? answer: no under sizing.7.Was the femur or tibia excessively resected/joint line raised during the primary surgery that led to the instability? answer: no over resection.8.Please confirm if there was any indication that the patient's knee was unstable prior to the revision surgery? answer: it is assumed the instability happened from the fall.9.A.Was instability related to polyethylene wear? a.Was there any reported malposition of components that led to the instability? c.Were any components undersized on the primary surgery that led to the instability? was the femur or tibia excessively resected/joint line raised during the primary surgery that led to the instability? 10.Was there any adverse consequences that affected the patient because of fall? answer: already answered.11.The event description mentioned that rp rev tray was used in the primary case due to high bmi so did not have to change it.Was a previous revision involving explanation of depuy products already reported in our system? if yes please provide reference number.Answer: a revision tibial tray was used in the primary tka.There was not a revision surgery with this patient prior to the fall.

• Brand Name: ATTUNE CR RP INSRT SZ4 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11148630
• Report Number: 1818910-2021-00815
• Device Sequence Number: 608236
• Product Code: JWH
• UDI-Device Identifier: 10603295047643
• UDI-Public: 10603295047643
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• 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): 12/31/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1516-30-407
• Device Catalogue Number: 151630407
• Device Lot Number: 9353708
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 01/21/2021; 02/17/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 01/28/2021; 02/17/2021
• 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 4 CEM; COMPETITOR BONE CEMENT; UNK KNEE TIBIAL TRAY ATTUNE REVISION; ATTUNE CR FEM RT SZ 4 CEM; COMPETITOR BONE CEMENT; UNK KNEE TIBIAL TRAY ATTUNE REVISION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 116