MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 32MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-032

Device Problem Off-Label Use (1494)

Patient Problems Fall (1848); Fatigue (1849); Muscle/Tendon Damage (4532)

Event Date 09/26/2019

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

On (b)(6) 2019, the patient underwent a second left knee revision with an exchange of the competitor tibial insert and surgical intervention to correct an extensor mechanism failure with partial quad tendon tear and disruption of vmo.The patient was experiencing weakness and falls prior to revision.The surgeon noted surgical intervention involving the depuy patellar component, however, the patellar component was retained.Task initiated to create a new pc to capture second revision.Doi: (b)(6) 2016 (patella), doi: (b)(6) 2019 (competitor insert, femoral and tibial components captured in (b)(4)) dor: (b)(6) 2019.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE MEDIAL DOME PAT 32MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11731564
• MDR Text Key: 247488483
• Report Number: 1818910-2021-08843
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056676
• UDI-Public: 10603295056676
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 1518-20-032
• Device Catalogue Number: 151820032
• Device Lot Number: 8147361
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STRYKER FEMORAL COMPONENT; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT; STRYKER STEM CEMENTED; STRYKER STEM CEMENTED; STRYKER TIBIAL BASEPLATE; STRYKER TIBIAL INSERT; SYNTHES SCREW; SYNTHES SCREW; STRYKER FEMORAL COMPONENT; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT; STRYKER STEM CEMENTED; STRYKER STEM CEMENTED; STRYKER TIBIAL BASEPLATE; STRYKER TIBIAL INSERT; SYNTHES SCREW; SYNTHES SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR