MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 9 8MM; KNEE FEMORAL ACCESSORY

Model Number	1549-09-002
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/01/2020
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
Patient was undergoing a revision of a revision (no depuy product) on (b)(6) 2020 ( (b)(6) hospital) all components were removed (non depuy) and an attune revision system was being utilised.The attune femoral construct required posterior augments on both the medial and lateral posterior condyles.When attempting to connect the lateral 8mm (size 9) posterior augment, this augment would not seat / connect correctly - it would initially seat but when an attempt was made to tighten this augment down using the torque driver, the augment would lift showing a gap of approximately 1mm.A number of attempts were made to seat this augment by releasing the screw, re seating the augment and re fastening the screw.None worked.As an alternative size 9 x 8mm posterior augment was available, this was opened and when attaching to the femur, seated correctly.I have requested the faulty augment be decontaminated and kept in order for this to be looked at.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device was unable to replicate the reported event.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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: ATTUNE POS FEM AUG SZ 9 8MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10271909
• Report Number: 1818910-2020-15816
• Device Sequence Number: 19637774
• Product Code: JWH
• UDI-Device Identifier: 10603295383161
• UDI-Public: 10603295383161
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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: 1549-09-002
• Device Catalogue Number: 154909002
• Device Lot Number: J3656N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/27/2020
• 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 POS FEM AUG SZ 9 8MM; ATTUNE POS FEM AUG SZ 9 8MM
• Patient Age: 73 YR