MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient had a cortisone injection to the left knee on (b)(6) 2020. On (b)(6) 2020 medical records note the patient presents with bilateral knee pain. Updated assessment noted left knee status post revision knee arthroplasty for loose component with a secondary history of pes anserine bursitis treated with a cortisone injection with good results. Doi: (b)(6) 2014; dor: mar 19, 2019 (tibia, femur and insert - captured in (b)(4)); doe: (b)(6) 2020; left knee.

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 related reported incidents against the provided product code/lot number combination since (b)(6) 2015. 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. 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). Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE MEDIAL DOME PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• 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: 11444262
• Report Number: 1818910-2021-04683
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056683
• UDI-Public: 10603295056683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/12/2017
• Device Model Number: 1518-20-035
• Device Catalogue Number: 151820035
• Device Lot Number: 3473438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Treatment(s): ATTUNE CEMENTED STEM 14X30MM; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 14MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE MEDIAL DOME PAT 35MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN TIB SLV M/L 29MM FULL POR; ATUNE REV RP TIB BASE SZ 4 CEM; DEPUY/CMW 2G; DEPUY/CMW 2G; DEPUY/CMW 2G; DEPUY/CMW 2G; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 14MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE MEDIAL DOME PAT 35MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN TIB SLV M/L 29MM FULL POR; ATUNE REV RP TIB BASE SZ 4 CEM; DEPUY/CMW 2G; DEPUY/CMW 2G; DEPUY/CMW 2G; DEPUY/CMW 2G
• Patient Outcome(s): Required Intervention