MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL STEM C-STEM

Catalog Number UNK HIP FEMORAL STEM C-STEM

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  malfunction  

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 surgeon was forced to cement c stem in with no cementralizer.No cementralizer available due to back orders.Account has total of 6 on back order.Stem ended in varus position.No surgical delay.

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 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 : a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.Corrected: e1, h8.

• Brand Name: UNK HIP FEMORAL STEM C-STEM
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11605553
• MDR Text Key: 243505320
• Report Number: 1818910-2021-06891
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• 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: 03/24/2021

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: UNK HIP FEMORAL STEM C-STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK HIP FEMORAL STEM C-STEM; UNKNOWN BONE CEMENT; UNK HIP FEMORAL STEM C-STEM; UNKNOWN BONE CEMENT