MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 3 CEM; KNEE FEMORAL

Model Number	1504-40-103
Medical Device Problem Codes	Noise, Audible (3273); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
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 patellar clunk syndrome or tendonosis quadriceps event is not serious and is considered moderate there is a remote possibility the event is related to the device and probably related to the procedure.Date of implantation: (b)(6) 2018; date of event (onset): (b)(6) 2019; (left knee).
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 will be filed as appropriate.

• Brand Name: ATTUNE CRS FEMORAL LT SZ 3 CEM
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9739016
• Report Number: 1818910-2020-05616
• Device Sequence Number: 19433385
• Product Code: JWH
• UDI-Device Identifier: 10603295042167
• UDI-Public: 10603295042167
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1504-40-103
• Device Catalogue Number: 150440103
• Device Lot Number: HN0834
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/30/2020
• 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 14X30MM; ATTUNE CRS RP INSRT SZ 3 16MM; ATTUNE POS FEM AUG SZ 3 4MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM18X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL AUGMENT; UNKNOWN KNEE FEMORAL STEM
• Patient Age: 46 YR
• Patient Weight: 110