MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 9 CEM; KNEE TIBIAL TRAY

Model Number	1506-80-009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that i&d right knee was performed with temporary spacers.Last surgery was (b)(6) 2021 with surgeon at hospital for a poly swap.On (b)(6) 2022, surgeon removed everything but patella and replaced with femur and rp insert as temp spacer.No additional information provided.Der was already provided for this patient back for the (b)(6) 2021 poly swap.The sales rep wanted to provide the complaint number for that der, it is: (b)(4).1st doi: (b)(6) 2019.2nd doi: (b)(6) 2021.Dor: (b)(6) 2022.Affected side: right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : device associated with this report was not received for examination.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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 manufacturing records evaluation (mre) was not performed.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specification at the time it was released for distribution.

• Brand Name: ATTUNE RP TIB BASE SZ 9 CEM
• Common Device Name: 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: 15391810
• Report Number: 1818910-2022-17510
• Device Sequence Number: 14997218
• Product Code: NJL
• UDI-Device Identifier: 10603295492214
• UDI-Public: 10603295492214
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 09/09/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1506-80-009
• Device Catalogue Number: 150680009
• Device Lot Number: 8929101
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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 PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ8 5MM; ATTUNE RP TIB BASE SZ 9 CEM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male