MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 4 4MM; KNEE FEMORAL ACCESSORY

Model Number	1547-04-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); No Code Available (3191)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Clinical adverse event received for knee stiffness.Event is serious and is considered severe.Event is definitely not related to device and is probably related to procedure.Date of implantation: (b)(6) 2019.Date of event (onset): (b)(6) 2019; (right 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.H10 additional narrative:  corrected: h6 (patient).Removed code for minor injury and replaced with no code available (3191) to capture surgical intervention.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 : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.
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 that 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 recon described in this report.H11 additional narrative: added: a3a, g4.Pma/ 510(k), h6 health effect clinical code.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE DIST FEM AUG SZ 4 4MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10378976
• Report Number: 1818910-2020-17732
• Device Sequence Number: 17026437
• Product Code: JWH
• UDI-Device Identifier: 10603295382713
• UDI-Public: 10603295382713
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/28/2020

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: 1547-04-001
• Device Catalogue Number: 154704001
• Device Lot Number: J08C55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020; 10/07/2020; 11/26/2025
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 08/14/2020; 10/09/2020; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• 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 RT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 10MM; ATTUNE DIST FEM AUG SZ 4 4MM; ATTUNE POS FEM AUG SZ 4 4MM; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 4 CEM; ATTUNE CRS FEMORAL RT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 10MM; ATTUNE DIST FEM AUG SZ 4 4MM; ATTUNE POS FEM AUG SZ 4 4MM; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 4 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG