MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
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 patient had a left revision of a primary attune patella on (b)(6) 2023 by the revising surgeon at (b)(6) hospital.The patient's primary left knee surgery was done at the same hospital on (b)(6) 2017 by the primary surgeon.The patient complained of knee pain.The x-rays show the patella tracking improperly.Upon revision surgery, the worn patella was removed and a new one implanted as well as patella tendon release.The original patella implant was well fixed.The patella implant which was removed, along with the cement type that was used for the primary surgery were attached.Smartset cement was used.There was no time delay in this surgery.The patella implant failed due to patella tracking issue, not due to a faulty implant.Current x-rays, original implant log from 2017, and picture of the implant were attached.Doi: (b)(6) 2017.Dor: (b)(6) 2023.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that the patient had a left revision of a primary attune patella on (b)(6) 2023 by the revising surgeon at (b)(6) hospital.The patient's primary left knee surgery was done at the same hospital on (b)(6) 2017 by the primary surgeon.The patient complained of knee pain.The x-rays show the patella tracking improperly.Upon revision surgery, the worn patella was removed and a new one implanted as well as patella tendon release.The original patella implant was well fixed.The patella implant which was removed, along with the cement type that was used for the primary surgery were attached.Smartset cement was used.There was no time delay in this surgery.The patella implant failed due to patella tracking issue, not due to a faulty implant.Current x-rays, original implant log from 2017, and picture of the implant were attached.Doi: (b)(6) 2017.Dor: (b)(6) 2023.Affected side: left knee.The product was not returned to depuy synthes, however photos were provided for review.See attachment [(b)(4) der long].The photo and x-ray investigation found nothing indicative of a device nonconformance.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 unconfirmed as there is not enough evidence that the observed condition of the [attune ps fem lt sz 5 cem] would have contributed to the reported adverse allegation.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FEM LT SZ 5 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17719087
• Report Number: 1818910-2023-18403
• Device Sequence Number: 15258851
• Product Code: JWH
• UDI-Device Identifier: 10603295041627
• UDI-Public: 10603295041627
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 09/11/2023

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: 150410105
• Device Lot Number: 8490470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS RP INSRT SZ5 6MM; ATTUNE RP TIB BASE SZ 5 CEM; HP STRL QUICK DRL PINS; HP STRL THREADED PINS HEADED; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male