MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71337656

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Injury (2348)

Event Date 12/07/2018

Event Type  Injury  

Event Description

It was reported that, during surgery, liner was difficult to get into the r3 cup.Surgeon broached for the steam and trialed, when patient dislocated the hip the liner popped out.This required exchange liner from 32mm to 36mm and minor delay was reported.If smith and nephew back was used is unknown.

Manufacturer Narrative

The r3 20 deg xlpe acet lnr 32mm x 56mm was returned and evaluated.The lab analysis concluded, damage was seen on the locking tabs.A scratch was seen on the rim of the liner.Plastic deformation was seen on the inner rim of the liner.This damage likely occurred when the liner dissociated or during removal.Dimensional analysis determined that the outer profile including the locking tabs and splines was outside of the specification; however, the plastic deformation seen on the liner may have resulted in invalid dimensional analysis.No material or manufacturing deviations were identified during this investigation.The cause of the liner dissociation could not be determined.The clinical/medical team concluded, no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.The product evaluation revealed no material or manufacturing deviations during the investigation.The cause of the liner dissociation could not be determined.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.If new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 32MM X 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8286836
• MDR Text Key: 134398397
• Report Number: 1020279-2019-00328
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598516
• UDI-Public: 03596010598516
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71337656
• Device Lot Number: 18FM11322
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other