MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ9 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-906
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/05/2020
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 haemarthrosis.Event is serious and is considered moderate.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: injected medication-adductor block to relieve pain; physical therapy.
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.
Event or Problem Description
Additional information received indicating that all confirms that the original clinical adverse event was reported in error for this study subject.The information applied to a different study subject, which is confirmed to have been addressed.There is no adverse event associated with this current complaint.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.  h10 additional narrative:  udi: (b)(4).Added: b5.Corrected: h6(patient codes).H6 patient code: no code available (3191) used to capture (absence of treatment).
Additional Manufacturer Narrative
Product complaint # (b)(4).Mfr# 1818910-2020-06252 is being retracted since it was reported in error.Additional information received confirms that the original adverse event was reported in error for this study subject.

• Brand Name: ATTUNE PS RP INSRT SZ9 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9764914
• Report Number: 1818910-2020-06252
• Device Sequence Number: 2456676
• Product Code: NJL
• UDI-Device Identifier: 10603295052999
• UDI-Public: 10603295052999
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/09/2020

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: 1516-50-906
• Device Catalogue Number: 151650906
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/09/2020; 03/09/2020; 04/17/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/16/2020; 03/25/2020; 04/20/2020
• 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 9; ATTUNE PS RP INSRT SZ9 6MM; ATTUNE RP TIB BASE SZ 9 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 122