MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 7 4MM; KNEE FEMORAL ACCESSORY

Model Number 1547-07-001

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

Patient Problem Loss of Range of Motion (2032)

Event Date 05/01/2021

Event Type  Injury  

Event Description

Subject id: (b)(6).Study: dsj-2016-02 new clinical adverse event received for right knee limited range of motion.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2021.Date of event: unk (b)(6) 2021.(right knee).Treatment: awaiting manipulation under anesthesia.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 7 4MM
• Type of Device: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14655610
• MDR Text Key: 293877723
• Report Number: 1818910-2022-10651
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295382812
• UDI-Public: 10603295382812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1547-07-001
• Device Catalogue Number: 154707001
• Device Lot Number: JC0824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUN REV OFFST STM ADPTR 4MM; ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FB INSRT SZ 7 16MM; ATTUNE CRS FEMORAL RT SZ 7 CEM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 7 8MM; ATTUNE POS FEM AUG SZ 7 8MM; ATUN PRESSFIT STR STEM24X110MM; ATUNE CRS FB TIB BASE SZ 6 CEM; ATUNE PRESSFIT STR STEM22X60MM; COMPETITOR CEMENT MANUFACTURER (STRYKER); COMPETITOR CEMENT MANUFACTURER (STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic