MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 14X140; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number 1976-14-140

Device Problems Device-Device Incompatibility (2919); Difficult to Open or Remove Packaging Material (2922)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 06/17/2019

Event Type  malfunction  

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

Product details: reclaim stem 14mm x 140mm straight stem.1976-14-140 lot h64477 date: 17/6/2019.Issue: femoral canal prepared as per surgical technique.Above femoral stem implanted as per surgical technique.When surgeon went to remove taper protector sleeve it would not disengage.Proximal aspect of sleeve eventually broke leaving distal part in situ.Stem then had to be removed and another implant opened and implanted in its place.Case length was extended by approx 15 minutes.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.The report has been confirmed using customer provided photographs.The root cause is attributed to design.Corrective action was established via the depuy corrective and preventive action system.Additional corrective action is not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

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 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.H6 patient code: no code available (3191) used to capture the insufficient information and surgery prolonged.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: RECLAIM DISTAL TAPERED 14X140
• Type of Device: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8771704
• MDR Text Key: 150416526
• Report Number: 1818910-2019-97829
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295076995
• UDI-Public: 10603295076995
• Combination Product (y/n): N
• PMA/PMN Number: K102080
• 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: 06/18/2019

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 Model Number: 1976-14-140
• Device Catalogue Number: 197614140
• Device Lot Number: H64477
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 08/21/2019; 09/22/2020
• Supplement Dates FDA Received: 08/21/2019; 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1