MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL RT SZ 9 CEM; KNEE FEMORAL

Model Number	1504-40-209
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
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 ps was undertaking revision knee surgery on (b)(6) 2020 ( (b)(6)) at time of opening the components, it was noted that the attune revision femoral component (size 9 right) packaging was distorted and had the appearance that the clear packaging had melted (to some extent - see pictures.The packaging was checked visibly for any possible perforations and appeared in tact and as there was no other alternatives available in the hospital or in the local area, this was opened.On opening the first layer of sterile packaging, the sterile scrub nurse was unable to remove the second layer in the usual manner (due to the distortion n the packaging.As there was no other alternative, the inner white peel cover was removed and the femoral component was taken sterile from this "inner packaging".
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary : the device associated with the reported event was not returned for evaluation.Examination of the provided photographs confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with the reported event was not returned for evaluation.Examination of the provided photographs confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 CRS FEMORAL RT SZ 9 CEM
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10250572
• Report Number: 1818910-2020-15374
• Device Sequence Number: 470484
• Product Code: JWH
• UDI-Device Identifier: 10603295042327
• UDI-Public: 10603295042327
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2020

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: 1504-40-209
• Device Catalogue Number: 150440209
• Device Lot Number: J22J29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 11/05/2020; 03/23/2021
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 11/06/2020; 03/24/2021
• 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 9 CEM.
• Patient Age: 60 YR