MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 4; HIP FEMORAL STEM

Model Number 1010-11-040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 05/01/2019

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

Clinical adverse event received for heterotopic ossification.Limited range of motion.Event is serious and is considered moderate.Event is definitely not related to device and definitely related to procedure.Date of implant: (b)(6) 2019, date of event: (b)(6) 2019, (right hip).Treatment: radiation and excision of heterotopic ossification.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

Event Description

Medical records received and were reviewed: revision operative notes (b)(6) 2020 indicate the patient received a right total hip surgical excision due to pain, limited range of motion, stiffness and heterotopic ossification.The surgical excision of heterotopic ossification along with irrigation and debridement was completed without indication of complication by the surgeon.No implants were revised.

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.

• Brand Name: ACTIS COLLARED STD SIZE 4
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10656671
• MDR Text Key: 210644790
• Report Number: 1818910-2020-21863
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295380443
• UDI-Public: 10603295380443
• Combination Product (y/n): N
• PMA/PMN Number: K160907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1010-11-040
• Device Catalogue Number: 101011040
• Device Lot Number: J2338Z
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACTIS COLLARED STD SIZE 4; ALTRX LIP LNR 28IDX48OD; DELTA CER HEAD 12/14 28MM +5; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 48MM; ACTIS COLLARED STD SIZE 4; ALTRX LIP LNR 28IDX48OD; DELTA CER HEAD 12/14 28MM +5; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 48MM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 64