MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Contracture (4528)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint#: (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 this patient had a primary knee done with attune ps rp.The patient had approximately a 25 degree flexion contracture after the total knee replacement.The patient was being revised to address that contracture.The doctor removed the size 5 - 10mm ps rp insert and implanted a size 5 - 7mm ps rp insert to regain full extension.The doctor also resurfaced the patella which was not done during the primary procedure.He implanted a size 38mm done patella.Doi: unknown, dor: on (b)(6) 2024, affected side: right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that this patient had a primary knee done with attune ps rp.Patient had approximately a 25 degree flexion contracture after the total knee replacement.Patient was being revised to address that contracture.Doctor removed the size 5 - 10mm ps rp insert and implanted a size 5 - 7mm ps rp insert to regain full extension.Doctor also resurfaced the patella which was not done during the primary procedure.He implanted a size 38mm done patella.The product was not returned to j&j medtech orthopaedics; however, a photo was provided for review.The photo investigation revealed marks on the surface that appear to be from the extraction process, however, there is nothing indicative of a device nonconformance.A search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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 not confirmed as the observed condition of the attune ps rp insrt sz 5 10mm would not have contributed to the reported adverse event.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 reported complaint condition.As part of j&j medtech orthopaedics 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: a search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
Event or Problem Description
Additional information received states that there was no patient consequence/s and no surgical delay.

• Brand Name: ATTUNE PS RP INSRT SZ 5 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20938656
• Report Number: 1818910-2024-25402
• Device Sequence Number: 8323708
• Product Code: NJL
• UDI-Device Identifier: 10603295052463
• UDI-Public: (01)10603295052463(17)270131(10)3721611
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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 Catalogue Number: 151650510
• Device Lot Number: 3721611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 01/29/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 12/20/2024; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male