MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FB INSRT SZ 7 8MM; KNEE TIBIAL INSERT

Model Number 1517-00-708

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 05/06/2020

Event Type  Injury  

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 Description

Clinical adverse event received for entrapment right infrapatellaris knee right event is not serious and is considered moderate there is a remote possibility that the event is related to device and is possibly related to procedure.Date of implantation: (b)(6) 2019 date of event (onset): (b)(6) 2020 (right knee), treatment: none.

Manufacturer Narrative

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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.Corrective action was not indicated.

• Brand Name: ATTUNE CRS FB INSRT SZ 7 8MM
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10684754
• MDR Text Key: 211514825
• Report Number: 1818910-2020-22434
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295055037
• UDI-Public: 10603295055037
• Combination Product (y/n): N
• PMA/PMN Number: K160700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1517-00-708
• Device Catalogue Number: 151700708
• Device Lot Number: H83605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUN REV OFFST STM ADPTR 4MM; ATTUN REV OFFST STM ADPTR 6MM; ATTUNE CRS FEMORAL RT SZ 7 CEM; ATTUNE DIST FEM AUG SZ 7 8MM; ATTUNE DIST FEM AUG SZ 7 8MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 8MM; ATUNE CRS FB TIB BASE SZ 5 CEM; ATUNE PRESSFIT STR STEM12X60MM; ATUNE PRESSFIT STR STEM16X60MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; ATTUN REV OFFST STM ADPTR 4MM; ATTUN REV OFFST STM ADPTR 6MM; ATTUNE CRS FEMORAL RT SZ 7 CEM; ATTUNE DIST FEM AUG SZ 7 8MM; ATTUNE DIST FEM AUG SZ 7 8MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 8MM; ATUNE CRS FB TIB BASE SZ 5 CEM; ATUNE PRESSFIT STR STEM12X60MM; ATUNE PRESSFIT STR STEM16X60MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
• Patient Outcome(s): Required Intervention