MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 5 8MM; KNEE TIBIAL INSERT

Model Number	1517-10-506
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	03/01/2022
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
Poly change from revision knee 3 years ago.No issue with poly, limited flexsion ~85° present in both knees (one dps / one exatech.Doi: unknown.Dor: (b)(6) 2022.Unknown knee.
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.Corrected: d1, d4 (catalog), d6b, g1 and h6 (impact code).Removed date of revision since there was no depuy product revised.
Event or Problem Description
Additional information was received indicated the following: 1.Was surgery time extended? if yes, what is the duration of the delay? no delay.2.What is the affected side involved in this event? left side.3.On 01-mar-2022 were any depuy products revised/explanted? no.4.How did the surgeon resolve the limited flexion issue? after initial exposure, scar tissue was extensively cleared and stretching of the remaining soft tissues resulted in an outcome rom and resting state the surgeon was happy with.5.Usage for the patient's revision procedure 3 years ago has been identified in the kit diary (see below).To your knowledge were both sides revised on (b)(6) 2019? no, only one side has a revision, the other side has more recently had a primary done using zimmer (mid-late 2021).I cannot speak to the double up with stems and sleeves.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 5 8MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13770319
• Report Number: 1818910-2022-04720
• Device Sequence Number: 3967137
• Product Code: NJL
• UDI-Device Identifier: 10603295055914
• UDI-Public: 10603295055914
• 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: 2019
• 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): 03/15/2022

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: 1517-10-506
• Device Catalogue Number: 151710508
• Device Lot Number: 8969262
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 03/18/2022; 04/04/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 03/26/2022; 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• 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 CRS FEMORAL LT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 8MM; ATTUNE DIST FEM AUG SZ 5 8MM; ATTUNE DIST FEM AUG SZ 5 8MM; ATUN FEM SLV M/L 30MM HALF POR; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 4 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown