MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM NAR POR PS LT SZ 5; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-11-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fibrosis (3167); No Code Available (3191)
Date of Event	03/25/2020
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 arthrofibrosis left knee.Event is serious and is considered mild.Event is not related to device and is definitely related to procedure.Date of implantation: (b)(6) 2019.Date of event (onset): (b)(6) 2020; (left knee).Treatment: manipulation under anesthesia.
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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: he 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Additional Manufacturer Narrative
Product complaint # : (b)(4).H6 patient code: no code available (3191) used to capture the absence of treatment.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened. .
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  corrected: h6 (patient).No code available (3191) was used to capture serious injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE FEM NAR POR PS LT SZ 5
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9954622
• Report Number: 1818910-2020-10674
• Device Sequence Number: 16835531
• Product Code: JWH
• UDI-Device Identifier: 10603295041986
• UDI-Public: 10603295041986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup,Followup,Followup
• Report Date (Section B): 03/31/2020

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: 1504-11-125
• Device Catalogue Number: 150411125
• Device Lot Number: 8898324
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 04/17/2020; 04/27/2020; 05/13/2020; 07/24/2020; 04/17/2021
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 04/24/2020; 04/27/2020; 05/13/2020; 08/03/2020; 04/19/2021
• 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 FEM NAR POR PS LT SZ 5; ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS RP INSRT SZ 5 7MM; ATTUNE RP TIB BASE SZ 6 POR; DEPUY/CMW 2G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 79