MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN PRESSFIT STR STEM16X110MM; KNEE STEMS

Model Number	1513-16-110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Review of the information, photographs and physical device, can confirm the reported allegation.The threaded proximal tip from the device was found broken.The broken bit was returned for examination.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent the surgery via tka.The surgery was completed successfully without any surgical delay.After the surgery, there was the possibility of metallosis due to micro-motion of the taper lock between femoral sleeve and femoral component.There was also the possibility of looseness due to metalosis.The revision surgery was done on an unknown date.The revision surgery was completed successfully without any surgical delay.The surgeon commented that it might be a loose taper lock.He want the investigation to identify the source of the metal debris.No further information is available.

• Brand Name: ATUN PRESSFIT STR STEM16X110MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16746649
• Report Number: 1818910-2023-08027
• Device Sequence Number: 16963138
• Product Code: JWH
• UDI-Device Identifier: 10603295043676
• UDI-Public: 10603295043676
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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: 1513-16-110
• Device Catalogue Number: 151316110
• Device Lot Number: J0115H74
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CRS FEMORAL LT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 16MM; ATUN FEM SLV M/L 30MM HALF POR; ATUN PRESSFIT STR STEM16X110MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male