MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS STD NK SZ8/9; FEMORAL STEM TRIALS

Model Number 2010-02-500

Device Problems Loose or Intermittent Connection (1371); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/03/2020

Event Type  malfunction  

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 Description

It was reported that the actis trial neck segments loose tolerance, and slightly disengaging when trialing hip.No problems were caused due to worn instrument.New neck segments were swapped to address this issues.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.

• Brand Name: ACTIS STD NK SZ8/9
• Type of Device: FEMORAL STEM TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10606356
• MDR Text Key: 209163319
• Report Number: 1818910-2020-21210
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393825
• UDI-Public: 10603295393825
• Combination Product (y/n): N
• PMA/PMN Number: K150862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2010-02-500
• Device Catalogue Number: 201002500
• Device Lot Number: PG277152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1