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

Catalog Number 101011040

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

Patient Problem Pain (1994)

Event Date 01/27/2021

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 to address pain.Doi: unknown, dor: (b)(6) 2021, affected side: unknown.

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.

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 : for allegations of pain a device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430, review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.

• 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: 11322096
• MDR Text Key: 231619744
• Report Number: 1818910-2021-02898
• 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: 01/27/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101011040
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/12/2021; 03/10/2021
• Supplement Dates FDA Received: 02/17/2021; 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 36 +12 CERAMIC HEAD; 36X52 NEUTRAL LINER; 52 SECTOR GRIPTION CUP; ACTIS 4 STD; DELTA CER HEAD 12/14 36MM +12; PINNACLE SECTOR II CUP 52MM; 36 +12 CERAMIC HEAD; 36X52 NEUTRAL LINER; 52 SECTOR GRIPTION CUP; ACTIS 4 STD
• Patient Outcome(s): Required Intervention