MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 6 8MM; KNEE FEMORAL ACCESSORY

Model Number	1547-06-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	04/06/2020
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.
Event or Problem Description
Patient was revised due to an infection in his knee, all implants removed, surgeon stated the infection was the same bug that required his primary implants to be removed in the first place.Unsure if the implants removed from the primary were ours was surgery delayed due to the reported event? --> unknown, was procedure successfully completed? --> unknown, were fragments generated? --> unknown, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> infection reason for this revision.It was the same original bug the patient had when his first implant was revised., was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> no, is the patient part of a clinical study --> unknown, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
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.Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.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.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
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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE DIST FEM AUG SZ 6 8MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9972165
• Report Number: 1818910-2020-10892
• Device Sequence Number: 19520649
• Product Code: JWH
• UDI-Device Identifier: 10603295382782
• UDI-Public: 10603295382782
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2020

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: 1547-06-002
• Device Catalogue Number: 154706002
• Device Lot Number: HM6241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 04/20/2020; 05/01/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 04/23/2020; 05/07/2020
• 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 CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 10MM; ATTUNE DIST FEM AUG SZ 6 8MM; ATTUNE DIST FEM AUG SZ 6 8MM; ATTUNE POS FEM AUG SZ 6 4MM; ATTUNE POS FEM AUG SZ 6 8MM; ATUN FEM SLV M/L 45MM HALF POR; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE PRESSFIT STR STEM18X60MM; ATUNE REV RP TIB BASE SZ 6 CEM; COMPETITOR CEMENT
• Outcome Attributed to Adverse Event: Required Intervention