MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151640805
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complaining to surgeon of 'clicking' in right knee replacement.The surgeon performed arthroscopy on patient's right knee and observed the poly insert to be loose.Converted to open procedure where it was discovered the poly insert was not engaged in the tibial tray and was loose.Poly insert removed, debridement and washout performed and new poly insert of same thickness inserted (size 8/5mm).Doi: (b)(6) 2023.Doe: (b)(6) 2023.Affected side: right.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : <
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).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: patient underwent primary right attune ps/rp tkr on [date].Complaining to surgeon of 'clicking' in right knee replacement.Today surgeon performed arthroscopy on patient's right knee and observed the poly insert to be loose.Converted to open procedure where it was discovered the poly insert was not engaged in the tibial tray and was loose.Poly insert removed, debridement and washout performed and new poly insert of same thickness inserted (size 8/5mm).Insert to be decontaminated for return and investigation.See attached photos.Surgeon is [surgeon], does not appear in contact search.Please send investigation email to sales rep.The product was not returned to depuy synthes, however photos were provided for review.See attachment (wheatley poly change mater rockhampton.Pdf).The photo investigation revealed that attune ps fb insrt sz 8 5mm had a deep scratch at the right section of the posterior surface, along with signs of deformation around the edges, based on the observed damaged condition, it suggests the posterior grooves on the underside of the tibial insert were not properly aligned with the undercut locking features of the tibial base.This would contribute to the disassociation reported confirmed with the heavy wear/deformation seen on the underside middle section of a condyle of the insert, suggesting the device was riding at least partially on the edge of the tibial tray, audible noise can be expected in this situation.Other damage can be seen, however is not possible to determine if it happened intra op, in vitro or during the extraction process.With the information provided is not possible to determine an exact root cause, however the investigation performed suspects de surgical process.The attune knee system surgical technique (dsus/jrc/0316/1437 rev.K) advises on pages 79-80, ¿for fixed bearing tibial components, angle the tibial insert posteriorly and slide the posterior tabs into the posterior undercuts of the tibial base.The fixed bearing tibial insert is impacted into place on the tibial base, using the fixed bearing insert impactor.Position an impactor at approximately 60 degrees on the insert so that the notch rests on the anterior edge of the center of the insert.Use a mallet to strike the fixed bearing insert impactor.¿ following these steps will successfully locking the insert into the base as intended.The overall complaint was confirmed as the observed condition of the attune ps fb insrt sz 8 5mm would contribute to the complained device issue.Based on the investigation findings, a potential cause cannot be established, and 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 a manufacturing record evaluation was performed for the finished device product description: attune ps fb insrt sz 8 5mm product code: 151640805 lot number: jw1885 and no non-conformances or manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary =patient underwent primary right attune ps/rp tkr on [date].Complaining to surgeon of 'clicking' in right knee replacement.Today surgeon performed arthroscopy on patient's right knee and observed the poly insert to be loose.Converted to open procedure where it was discovered the poly insert was not engaged in the tibial tray and was loose.Poly insert removed, debridement and washout performed and new poly insert of same thickness inserted (size 8/5mm).Insert to be decontaminated for return and investigation.See attached photos.Surgeon is [surgeon], does not appear in contact search.Please send investigation email to sales rep.The product was returned to depuy synthes for investigation.Visual examination revealed that attune ps fb insrt sz 8 5mm had a deep scratch at one section of the posterior surface, along with signs of deformation around the edges, based on the observed damaged condition, it suggests the posterior grooves on the underside of the tibial insert were not properly aligned with the undercut locking features of the tibial base.This would contribute to the disassociation reported confirmed with the heavy wear/deformation seen on the underside middle section of a condyle of the insert, suggesting the device was riding at least partially on the edge of the tibial tray, audible noise can be expected in this situation.Other damage can be seen, however is not possible to determine if it happened intra op, in vitro or during the extraction process.With the information provided is not possible to determine an exact root cause, however the investigation performed suspects de surgical process.The attune knee system surgical technique (dsus/jrc/0316/1437 rev.K) advises on pages 79-80, ¿for fixed bearing tibial components, angle the tibial insert posteriorly and slide the posterior tabs into the posterior undercuts of the tibial base.The fixed bearing tibial insert is impacted into place on the tibial base, using the fixed bearing insert impactor.Position an impactor at approximately 60 degrees on the insert so that the notch rests on the anterior edge of the center of the insert.Use a mallet to strike the fixed bearing insert impactor.¿ following these steps will successfully locking the insert into the base as intended.The overall complaint was confirmed as the observed condition of the attune ps fb insrt sz 8 5mm would contribute to the complained device issue.Based on the investigation findings, a potential cause cannot be established, and 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 =a manufacturing record evaluation was performed for the finished device product description: attune ps fb insrt sz 8 5mm product code: 151640805 lot number: jw1885 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: ATTUNE PS FB INSRT SZ 8 5MM
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17611269
• Report Number: 1818910-2023-17431
• Device Sequence Number: 7364818
• Product Code: JWH
• UDI-Device Identifier: 10603295050346
• UDI-Public: 10603295050346
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 151640805
• Device Lot Number: JW1885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 08/24/2023; 08/30/2023; 09/07/2023; 09/19/2023; 09/27/2023; 10/03/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 08/24/2023; 09/04/2023; 09/08/2023; 09/19/2023; 09/28/2023; 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FEM RT SZ 8 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male