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

Catalog Number 101012020

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 06/08/2020

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 this patient's primary hip was revised due to instability.She initially had a femoral neck fracture, which resulted in a total hip procedure.Approximately one month later her hip dislocated.It appeared upon x-ray examination that her femoral stem had subsided post operatively, which created the instability.During her revision hip procedure, her initial 28mm +5 ceramic femoral head was replaced by a longer 28mm +12 ceramic femoral head, which provided more hip stability.Doi: (b)(6) 2020, dor: (b)(6) 2020, affected side: left hip.

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.H10 additional narrative:  udi: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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 HIGH SIZE 2
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 10173794
• MDR Text Key: 195901363
• Report Number: 1818910-2020-14135
• Device Sequence Number: 1
• Product Code: KWL
• 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,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101012020
• Device Lot Number: J5941Z
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 28MM +5; DELTA CER HEAD 12/14 28MM +5; PINN MAR NEUT 28IDX46OD; UNKNOWN HIP ACETABULAR LINERS; DELTA CER HEAD 12/14 28MM +5; UNKNOWN HIP ACETABULAR LINERS
• Patient Outcome(s): Required Intervention