MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN PRESSFIT STR STEM10X110MM; KNEE STEMS

Model Number	1513-10-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The investigation could not draw any conclusions about the reported event.All available photographs were reviewed.Based on the photo evidence provided, complaint is not confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.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 after taking out a offset adapter from the box, the staff tried to unlock the nut for the positioning of the tibia.But that implant doesn't work at all.And then he decided to change the process.At first, he assembled the stem with offset adapter.Second, he tried to change the offset but the offset adapter was still locked and the stem was also locked as well.Unfortunately, he took out the new implant.There was a 20 minute surgical delay.

• Brand Name: ATUN PRESSFIT STR STEM10X110MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12680509
• Report Number: 1818910-2021-23216
• Device Sequence Number: 14478147
• Product Code: JWH
• UDI-Device Identifier: 10603295043492
• UDI-Public: 10603295043492
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1513-10-110
• Device Catalogue Number: 151310110
• Device Lot Number: J8384T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1