MAUDE Adverse Event Report: ACTIS COLLARED HIGH SIZE 2; HIP FEMORAL STEM

Model Number 1010-12-020

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

The patient was revised due to groin/thigh pain and loosening of the stem at the bone to implant interface.Doi: (b)(6) 2019, dor: (b)(6) 2021, (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot - the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ACTIS COLLARED HIGH SIZE 2
• Type of Device: HIP FEMORAL STEM
• MDR Report Key: 12599556
• MDR Text Key: 275477316
• Report Number: 1818910-2021-22477
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295380542
• UDI-Public: 10603295380542
• 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: 09/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 1010-12-020
• Device Catalogue Number: 101012020
• Device Lot Number: J06F60
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACTIS COLLARED HIGH SIZE 2.; ALTRX NEUT 32IDX50OD.; DELTA CER HEAD 12/14 32MM +5.; ACTIS COLLARED HIGH SIZE 2; ALTRX NEUT 32IDX50OD; DELTA CER HEAD 12/14 32MM +5
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR