MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV LPS INSRT XSM 18MM; KNEE TIBIAL INSERT

Catalog Number 151760218

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Loss of Range of Motion (2032); Joint Dislocation (2374); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 05/17/2023

Event Type  Injury  

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 Description

Failure of lps medical record was reviewed by clinician.On (b)(6) 2023, the patient was revised to address dislocation of the tibial tray and insert.It was noted that this event was due to condition of the soft tissue.The femoral component was also revised for unknown reason.Follow-up is being conducted.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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 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.

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.

Event Description

X-rays on (b)(6) 2023 revealed that the lps prosthesis was dislocated between the tibia part and the liner.The leg was bandaged and was neurologically intact.Subacute reoperation was carried out on (b)(6) 2023.The instability is not due to polyethylene wear on the liner and the prosthetic components were not malrotated.In the primary surgery on (b)(6) 2023 , we preoperatively accepted some shortening of the leg, which gave a better bending movement in the knee.It then turned out that the femur construct was too short in relation to the bone loss and the tension in the soft parts, so the prosthesis could dislocate.Dislocation was secondary to instability and not failure of the implant.We cannot answer point g ¿ the hinge pin is not separately packed with us.

Event Description

Medical records were received: on (b)(6) 2023, the patient was revised to address dislocation of the tibial tray and insert.It was noted that this event was due to condition of the soft tissue.The femoral component was also revised for unknown reason.

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.

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint #
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> (b)(4).Investigation summary
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> description of complaint (please supply specific details): please see attachment ¿failure of lps.Pdf¿ the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that attune rev lps insrt xsm 18mm presents nothing indicative of a device nonconformance nor damage that could have contribute to the reported issue.Based on the available information, the dislocation event was attributed to the condition of the soft tissue of the patient.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.The overall complaint was not confirmed as the observed condition of the attune rev lps insrt xsm 18mm would not contribute to the complained dislocation 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 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
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> a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.H3.

• Brand Name: ATTUNE REV LPS INSRT XSM 18MM
• Type of Device: 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: 17739631
• MDR Text Key: 323322983
• Report Number: 1818910-2023-18629
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295490999
• UDI-Public: 10603295490999
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K191779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/13/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 151760218
• Device Lot Number: JF6600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 10/02/2023; 10/18/2023; 11/09/2023; 12/18/2023; 01/11/2024
• Supplement Dates FDA Received: 10/12/2023; 10/18/2023; 11/23/2023; 01/02/2024; 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ATTUNE REV LPS INSRT XSM 18MM; ATTUNE REV LPS INSRT XSM 18MM; ATTUNE REV LPS INSRT XSM 18MM; ATTUNE REV LPS INSRT XSM 22MM; ATTUNE REV LPS INSRT XSM 22MM; ATTUNE REV LPS INSRT XSM 22MM; ATTUNE REV LPS INSRT XSM 22MM; ATTUNE REV LPS INSRT XSM 22MM; ATUN TIB SLV M/L 61MM FULL POR; ATUN TIB SLV M/L 61MM FULL POR; ATUN TIB SLV M/L 61MM FULL POR; ATUNE REV RP TIB BASE SZ 6 CEM; ATUNE REV RP TIB BASE SZ 6 CEM; ATUNE REV RP TIB BASE SZ 6 CEM; LPS DISTAL FEM COMP XSM LT; LPS DISTAL FEM COMP XSM LT; LPS DISTAL FEM COMP XSM LT; LPS DISTAL FEM COMP XSM LT; LPS DISTAL FEM COMP XSM LT; LPS DISTAL FEM COMP XSM LT; LPS FEM TO SLEEVE ADAPTER +0; LPS FEM TO SLEEVE ADAPTER +0; LPS FEM TO SLEEVE ADAPTER +0; LPS FEM TO SLEEVE ADAPTER +0; LPS FEM TO SLEEVE ADAPTER +0; LPS FEM TO SLEEVE ADAPTER +0; LPS FEM TO SLEEVE ADAPTER +5; LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 25MM; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED; UNK KNEE FEMORAL HINGE PIN LPS; UNK KNEE FEMORAL HINGE PIN LPS; UNK KNEE FEMORAL HINGE PIN LPS; UNKNOWN BONE CEMENT ( COMPETITOR ); UNKNOWN BONE CEMENT ( COMPETITOR ); UNKNOWN BONE CEMENT ( COMPETITOR ); UNKNOWN KNEE FEMORAL SLEEVE; UNKNOWN KNEE FEMORAL STEM; UNKNOWN KNEE FEMORAL STEM; UNKNOWN KNEE FEMORAL STEM; UNKNOWN KNEE TIBIAL TRAY; UNKNOWN KNEE TIBIAL TRAY; UNKNOWN KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male