MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DIST FEM AUG SZ 7 8MM; KNEE FEMORAL ACCESSORY

Model Number	1547-07-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/06/2020
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.No device associated with this report was received for examination.A worldwide complaint database search did find other reported incident(s) against the provided product/lot combination(s) but none were found to be related to a product defect.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
Event or Problem Description
Clinical adverse event received for entrapment right infrapatellaris knee right.Event is not serious and is considered moderate.There is a remote possibility that the event is related to device and is possibly related to procedure.Date of implantation: (b)(6) 2019; date of event (onset): (b)(6) 2020; (right knee).Treatment: surgical neurectomy.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search did find other reported incident(s) against the provided product/lot combination(s) but none were found to be related to a product defect.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.H10 additional narrative:.
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: added: b5 and h6 (patient) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
The patient has now received a neurectomy as treatment.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search did find other reported incident(s) against the provided product/lot combination(s) but none were found to be related to a product defect.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 : 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 DIST FEM AUG SZ 7 8MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10664949
• Report Number: 1818910-2020-21999
• Device Sequence Number: 3524263
• Product Code: JWH
• UDI-Device Identifier: 10603295382829
• UDI-Public: 10603295382829
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160700
• 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: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1547-07-002
• Device Catalogue Number: 154707002
• Device Lot Number: HW2120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 10/05/2020; 08/11/2021; 09/08/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 10/20/2020; 08/22/2021; 09/09/2021
• 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: ATTUN REV OFFST STM ADPTR 4MM; ATTUN REV OFFST STM ADPTR 6MM; ATTUNE CRS FB INSRT SZ 7 8MM; ATTUNE CRS FEMORAL RT SZ 7 CEM; ATTUNE DIST FEM AUG SZ 7 8MM; ATTUNE DIST FEM AUG SZ 7 8MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 8MM; ATUNE CRS FB TIB BASE SZ 5 CEM; ATUNE PRESSFIT STR STEM12X60MM; ATUNE PRESSFIT STR STEM16X60MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 96