MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 2; HIP FEMORAL STEM

Model Number 1010-12-020

Device Problem Osseointegration Problem (3003)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Inadequate Osseointegration (2646)

Event Date 12/03/2020

Event Type  Injury  

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 patient fell and resulted in a proximal femoral fracture that required revision of the femoral stem and hip ball.It was also indicated that there was a loosening of the stem at bone to implant interface.Doi: unknown; dor: (b)(6) 2020; right 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 manufacturing or material 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
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11028362
• MDR Text Key: 222065293
• Report Number: 1818910-2020-27191
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295380542
• UDI-Public: 10603295380542
• Combination Product (y/n): N
• PMA/PMN Number: K160907
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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: J81K04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 36MM +8.5; DELTA CER HEAD 12/14 36MM +8.5
• Patient Outcome(s): Required Intervention