MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 3 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-103
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
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
It was reported that the distributor reported that the femoral implant which is supposedly for the patient today is defective.The box outside seal is intact when opened, but the item itself is partly opened.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : the complaint unit was returned to depuy cork for review.Photographs of the complaint unit were provided by the customer.It was noted that the inner and outer blister of the packaging was melted/deformed.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 : product code 150410103 work order (b)(4) was manufactured on 13 july 2021.(b)(4) parts were manufactured to specification.There was (b)(4) scrap part associated with this lot.No non-conformances / manufacturing irregularities were identified.Deviations: there were no deviations associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.Device history review : a manufacturing record evaluation was performed for the finished device lot/serial/batch number, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: ATTUNE PS FEM LT SZ 3 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13025357
• Report Number: 1818910-2021-28352
• Device Sequence Number: 16617825
• Product Code: NJL
• UDI-Device Identifier: 10603295041603
• UDI-Public: 10603295041603
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

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: 1504-10-103
• Device Catalogue Number: 150410103
• Device Lot Number: 9800988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 02/01/2022; 03/14/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 02/16/2022; 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown