MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 15X140; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number 1976-15-140

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 09/28/2020

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

Hip revision surgery (right side) with the reclaim system.When placing the definitive stem, the protective cap is not removed, this step of the surgical technique was omitted, which remains impacted within the intramedullary canal.An attempt is made to remove but not all the fragments of the cap can be extracted, a lateral osteotomy is performed to extract the fragments.The definitive implants are placed.The surgical time was extended and fragments remained inside the bone.

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.Based on the information provided the root cause is attributed to inadvertent use error.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: RECLAIM DISTAL TAPERED 15X140
• Type of Device: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10683347
• MDR Text Key: 211461024
• Report Number: 1818910-2020-22351
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295077015
• UDI-Public: 10603295077015
• 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
• Report Date: 09/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1976-15-140
• Device Catalogue Number: 197615140
• Device Lot Number: HC2968
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention