MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 6 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-206

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

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/10/2021

Event Type  Injury  

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 Description

Patient underwent primary bilateral total knee replacement on (b)(6) 2020 where attune ps rp components were utilized.Patient reported recovering well until they sustained a fall.At the time of the fall, the right knee was injured.A quads mechanism tear was experienced but was not initially diagnosed.Patient has presented with ongoing pain of the right knee.X rays indicate that the patella has lowered.On opening the knee, the tear was evident and the extensor mechanism appeared thin and loose.The knee was checked - all components were well fixed, but the knee was loose through the range of motion, the healthcare professional elected to upsize the poly bearing from a 7mm to a 10mm - gaining additional stability.The quads tear was repaired and augmented by utilizing a lars ligament.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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 PS FEM RT SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12532463
• MDR Text Key: 273322884
• Report Number: 1818910-2021-21149
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041771
• UDI-Public: 10603295041771
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-206
• Device Catalogue Number: 150410206
• Device Lot Number: 9292157
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FEM LT SZ 6 CEM; ATTUNE PS RP INSRT SZ 6 7MM; ATTUNE RP TIB BASE SZ 5 CEM; UNK CEMENT GENTAMICIN; ATTUNE MEDIAL ANAT PAT 35MM; ATTUNE PS FEM LT SZ 6 CEM; ATTUNE PS RP INSRT SZ 6 7MM; ATTUNE RP TIB BASE SZ 5 CEM; UNK CEMENT GENTAMICIN
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR