MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUNE CRS FB TIB BASE SZ 3 CEM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY

Model Number	1506-40-003
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); No Code Available (3191)
Date of Event	04/29/2018
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 wound hematoma.Event is serious and is considered moderate.Event is possibly related to device and definitely related to procedure.Treatment includes irrigation and debridement.Patient reported dissatisfaction in a clinical survey.(right 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.
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.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 will be filed as appropriate.

• Brand Name: ATUNE CRS FB TIB BASE SZ 3 CEM
• Common Device Name: ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9954623
• Report Number: 1818910-2020-10670
• Device Sequence Number: 16835532
• Product Code: JWH
• UDI-Device Identifier: 10603295042778
• UDI-Public: 10603295042778
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1506-40-003
• Device Catalogue Number: 150640003
• Device Lot Number: 8623122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 03/30/2020; 05/29/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 04/27/2020; 06/01/2020
• 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 CEMENTED STEM 14X50MM; ATTUNE CEMENTED STEM 14X50MM; ATTUNE CRS FB INSRT SZ 3 14MM; ATTUNE CRS FEMORAL RT SZ 3 CEM; ATTUNE DIST FEM AUG SZ 3 8MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE POS FEM AUG SZ 3 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 95