MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 35MM HALF POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscular Rigidity (1968)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
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
Clinical adverse event received for right knee stiffness.Event is serious and is considered moderate.Event is possibly related to device and is definitely related to procedure.Date of implantation: (b)(6) 2019, date of event (onset): (b)(6) 2019, (right knee).Treatment: surgical intervention - manipulation of right knee under anesthesia.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATUN FEM SLV M/L 35MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11633693
• Report Number: 1818910-2021-07427
• Device Sequence Number: 3683411
• Product Code: JWH
• UDI-Device Identifier: 10603295436508
• UDI-Public: 10603295436508
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 1511-01-103
• Device Catalogue Number: 151101103
• Device Lot Number: J03K96
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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 RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 8MM; ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE POS FEM AUG SZ 6 4MM; ATUN FEM SLV M/L 35MM HALF POR; ATUN TIB SLV M/L 29MM FULL POR; ATUNE PRESSFIT STR STEM10X60MM; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 6 CEM; COPAL BONE CEMENT; COPAL BONE CEMENT; ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 8MM; ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE POS FEM AUG SZ 6 4MM; ATUN FEM SLV M/L 35MM HALF POR; ATUN TIB SLV M/L 29MM FULL POR; ATUNE PRESSFIT STR STEM10X60MM; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 6 CEM; COPAL BONE CEMENT; COPAL BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 75