MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 16X140; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number 1976-16-140

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2021

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

It was reported that the protection cover was difficult to remove.Several instruments were used to remove it.There was a 5 minute surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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.

• Brand Name: RECLAIM DISTAL TAPERED 16X140
• Type of Device: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12293188
• MDR Text Key: 265556690
• Report Number: 1818910-2021-17362
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295077039
• UDI-Public: 10603295077039
• 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
• Report Date: 07/19/2021

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 Model Number: 1976-16-140
• Device Catalogue Number: 197616140
• Device Lot Number: C52156
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1