MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 3 POR; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Model Number	1506-11-003
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Primary surgery(b)(6) 2021.Revision of implant (b)(6) 2022 (left side) revision of a loose and subsided attune rp tibial base size 3 procoat.Revised to an attune tibial tray with a metaphyseal sleeve and steam attune ps femur was retained attune ps/rp insert was changed.
Event or Problem Description
Additional information received indicated that there was no surgical delay reported.
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 : the device associated with this complaint was not received for examination.The photo investigation cannot confirm the reported allegation, indicators of loosening cannot be seen on the evidence provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s 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.

• Brand Name: ATTUNE RP TIB BASE SZ 3 POR
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14453457
• Report Number: 1818910-2022-09206
• Device Sequence Number: 15037974
• Product Code: NJL
• UDI-Device Identifier: 10603295416258
• UDI-Public: 10603295416258
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 05/19/2022

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 Model Number: 1506-11-003
• Device Catalogue Number: 150611003
• Device Lot Number: 9876480
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 05/23/2022; 07/29/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 05/31/2022; 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2021
• 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 DISPOSABLE PIN (6-PACK); ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FEM LT SZ 4 CEM; ATTUNE PS RP INSRT SZ4 6MM; ATTUNE RP TIB BASE SZ 3 POR; UNK ATTUNE KNEE TIBIAL TRAY; UNK KNEE FEMORAL ATTUNE PS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 100 KG