MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 6 8MM; KNEE FEMORAL ACCESSORY

Model Number	1549-06-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/15/2021
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
It was reported that the patient is a left bka and uses a wheel chair for mobility.Patient was using his r leg to ¿pull¿ his wheelchair across a grassy area and felt a ¿thunk¿.He did not present for exam until 2 weeks later, at which time x-rays showed the knee dislocated.Surgeon and assistant were unable to reproduce the dislocating mechanism while the patient was paralyzed for surgery.A femoral revision was performed, implanting a hinged construct.Doi: (b)(6) 2021, dor: (b)(6) 2021.Right knee.
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 POS FEM AUG SZ 6 8MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12288469
• Report Number: 1818910-2021-17312
• Device Sequence Number: 19526148
• Product Code: JWH
• UDI-Device Identifier: 10603295383086
• UDI-Public: 10603295383086
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1549-06-002
• Device Catalogue Number: 154906002
• Device Lot Number: J5002G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CEMENTED STEM 14X50MM; ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 16MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE POS FEM AUG SZ 6 8MM; ATTUNE POS FEM AUG SZ 6 8MM; COMPETITOR CEMENT MANUFACTURER; ATTUNE CEMENTED STEM 14X50MM; ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 16MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE POS FEM AUG SZ 6 8MM; ATTUNE POS FEM AUG SZ 6 8MM; COMPETITOR CEMENT MANUFACTURER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 175