MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS LT SZ 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-11-107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	05/28/2020
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 flexion contracture and insufficient range of motion in left knee.Event is not serious and is considered mild.Event is possibly related to both device and procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (left knee).Treatment: physical therapy.Product details: component type: attune ps fem lt sz 7 por.Catalog number: 150411107.Product id/lot number: 8904755.Component type: attune rp tib base sz 8 por.Catalog number: 150611008.Product id/lot number: 8748727.Component type: attune ps/rp insert sz 7 7mm.Catalog number: 151650707.Product id/lot number: 9436849.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.H10 additional narrative: corrected g4: since the previous medwatch reported has the wrong year (2202).
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.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.

• Brand Name: ATTUNE FEM POR PS LT SZ 7
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10220823
• Report Number: 1818910-2020-14847
• Device Sequence Number: 2565331
• Product Code: NJL
• UDI-Device Identifier: 10603295041924
• UDI-Public: 10603295041924
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2020

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: 1504-11-107
• Device Catalogue Number: 150411107
• Device Lot Number: 8904755
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/30/2202; 07/30/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/31/2020; 08/02/2020
• 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 FEM POR PS LT SZ 7; ATTUNE PS RP INSRT SZ 7 7MM; ATTUNE RP TIB BASE SZ 8 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 87