MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 P.F.C.*LINR 48-52/10DEG-22.225; PFC HIP STEM AND LINER IMPLANTS : HIP POLY ACETABULAR LINERS

Catalog Number 857738

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.(b)(4).

Event Description

The primary surgery was performed on an unknown date via tha with pfc hip implants (the product code were unknown).It was reported that the surgeon plans the revision surgery in (b)(6) 2020 by replacing the liner and the head due to the wear of the liner.The implanted devices were discontinued product.No further information is available.

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.No code available ((b)(4)) is used to capture device revision or replacement.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 : 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Type of Device: PFC HIP STEM AND LINER IMPLANTS : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds IN LS11 8DT; UK LS11 8DT
• MDR Report Key: 10808795
• MDR Text Key: 216953528
• Report Number: 1818910-2020-24163
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 857738
• Device Lot Number: 59425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 11/08/2020; 01/07/2021
• Supplement Dates FDA Received: 11/19/2020; 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (PFC HEAD); COMPETITOR BONE SCREW; COMPETITOR BONE SCREW; COMPETITOR BONE SCREW; P.F.C.*HIP HEAD 22.225MM +0MM; PFC*2 PRESS FIT FEM STEM SZ7/6; PFC*POR SHELL/MULTIHOLE SZ50MM
• Patient Age: 82 YR