MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 50MM HALF POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Date of Event	05/14/2019
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.
Event or Problem Description
Clinical adverse event received for low hb value, post-operative.Event is not serious and is considered mild.Event is definitely not related to device and is definitely related to procedure.
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
Update ad 03 dec 2019.Clinical database information received.The database reports pain, problems walking and in doing the patient's usual activities and discomfort.
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.  h6 patient code: no code available (3191) used to capture the walking difficulty.
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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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 associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) 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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) 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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATUN FEM SLV M/L 50MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9450719
• Report Number: 1818910-2019-122264
• Device Sequence Number: 14005608
• Product Code: MBH
• UDI-Device Identifier: 10603295436539
• UDI-Public: 10603295436539
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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 Model Number: 1511-01-106
• Device Catalogue Number: 151101106
• Device Lot Number: HU5300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 01/24/2020; 04/06/2020; 04/17/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/12/2019; 01/28/2020; 04/16/2020; 04/27/2020
• 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 LT SZ 6 CEM; 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 TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE PRESSFIT STR STEM18X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; COMPETITOR BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 70