MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 9 8MM; KNEE TIBIAL INSERT

Model Number	1517-10-908
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscular Rigidity (1968)
Date of Event	11/22/2021
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
This pc is linked to (b)(4) which reported on the non-depuy primary surgery.Patient underwent revision knee surgery on (b)(6) 2020 where an attune revision system was utilised (dr (b)(6), (b)(6) hospital).Depuy cement not utilised.Patient initially did well but over time has had progressive restriction to range of motion.Patient has presented with a stiff knee.Approximately 25 degrees of extension to 80 degrees flexion a decision was made to open the knee, remove as much scar tissue as possible and exchange the 8mm poly insert to a 6mm poly insert.All components were well fixed the range of motion was improved to approximately 5 degrees to 110 degrees.Doi: unknown (non-depuy products).Dor (1st): (b)(6) 2020.Dor (2nd): (b)(6) 2021.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays photographs were reviewed.It is not possible to confirm a depuy's product failure as well as a relation between the adverse event and the reported product.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 : 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 CRS RP INSRT SZ 9 8MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12933447
• Report Number: 1818910-2021-27183
• Device Sequence Number: 17360833
• Product Code: JWH
• UDI-Device Identifier: 10603295056355
• UDI-Public: 10603295056355
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 12/06/2021

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: 1517-10-908
• Device Catalogue Number: 151710908
• Device Lot Number: 9226283
• 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: 11/22/2021
• Supplement Date Received by Manufacturer: 12/20/2021; 01/24/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/13/2022; 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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 CRS FEMORAL RT SZ 9 CEM; ATTUNE CRS RP INSRT SZ 9 8MM; ATTUNE POS FEM AUG SZ 9 4MM; ATTUNE POS FEM AUG SZ 9 8MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 53MM FULL POR; ATUNE PRESSFIT STR STEM18X60MM; ATUNE REV RP TIB BASE SZ 7 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male