MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 16MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650516
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the attune ps rp poly with a lot number of 8869575 had an expiration date of 07/31/23 and was implanted (b)(6 23.The manufacture date was 08/09/18.They are looking for confirmation that dps has validated the poly as being sterile for 8 years rather than 5.Doi: (b)(6) 2023, dor: unknown, affected side: right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that the attune ps rp poly with a lot number of 8869575 had an expiration date of (b)(6) 2023 and was implanted (b)(6) 2023.The manufacture date was 08/09/18.They are looking for confirmation that dps has validated the poly as being sterile for 8 years rather than 5.Doi: (b)(6) 2023.Dor: unknown.Affected side: right knee.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).The photo investigation found the label exhibits the expiration date was (b)(6) 2023.However, according to (b)(4) the expiration date for this product was extended for three years.Based on the received information, the investigation was able to confirm the reported event.However, there was no product problem observed with attune ps rp insrt sz 5 16mm.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed.As the observed condition of the attune ps rp insrt sz 5 16mm would contribute to the complained device issue.  based on the investigation findings it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product code 151650516, work order (b)(4) was manufactured on 10-aug-2018.(b)(4) parts were manufactured per specification and all raw materials met specification.

• Brand Name: ATTUNE PS RP INSRT SZ 5 16MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17797967
• Report Number: 1818910-2023-19292
• Device Sequence Number: 7041618
• Product Code: NJL
• UDI-Device Identifier: 10603295052494
• UDI-Public: 10603295052494
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 151650516
• Device Lot Number: 8869575
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown