MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CEMENTED STEM 16X80MM; KNEE STEMS

Model Number	1512-16-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); No Code Available (3191)
Date of Event	06/12/2019
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 bone pain post tkr revision at tibia and inflammation of itb at gerdy's tubercle.Event is not serious and is considered moderate.Event is possibly related to device and definitely related to procedure.Doi: (b)(6) 2018; doe: (b)(6) 2019 (onset); (right knee).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 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: added: d6, e1 (facility name).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 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.Retracting the reported patient code medical device removal.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CEMENTED STEM 16X80MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9396832
• Report Number: 1818910-2019-119045
• Device Sequence Number: 16632688
• Product Code: JWH
• UDI-Device Identifier: 10603295043010
• UDI-Public: 10603295043010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 06/02/2019

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: 1512-16-080
• Device Catalogue Number: 151216080
• Device Lot Number: HB2195
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 01/20/2020; 06/30/2020; 10/23/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/23/2020; 07/03/2020; 10/29/2020
• 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 CRS FEMORAL RT SZ 4 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 4 4MM; ATTUNE PS RP INSRT SZ 4 12MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE REV RP TIB BASE SZ 4 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 89