MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSERT SZ 2 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151620207
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Disorder (2373); No Code Available (3191)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional 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.(b)(4).
Event or Problem Description
It was reported that patient had been experiencing difficulty with stairs.Upon examining, patient felt her knee was slightly, but globally unstable.Surgeon commented that this patient is hypermobile in other joints as well.Surgeon performed a poly exchange, removing a size 2 7mm cr fb insert and increasing it to a size 2 10mm insert.Surgeon was satisfied with the patient's stability after making this change.Also of note, a poly trial was broken during trial extraction.All pieces were recovered.Doi: (b)(6) 2018.Dor: (b)(6) 2019; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added: concomitant medical products:.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6.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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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: null.Device history batch: null.Device history review: null.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.

• Brand Name: ATTUNE CR FB INSERT SZ 2 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9450350
• Report Number: 1818910-2019-122225
• Device Sequence Number: 2114280
• Product Code: NJL
• UDI-Device Identifier: 10603295045304
• UDI-Public: 10603295045304
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2019

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 Catalogue Number: 151620207
• Device Lot Number: 510670
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/08/2019; 01/09/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/23/2019; 01/13/2020
• 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: ATTUNE CR FEM LT SZ 2 CEM; ATTUNE FB TIB BASE SZ 2 CEM; ATTUNE MEDIAL DOME PAT 35MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR