MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 28MM X 46MM; PROSTHE, HIP, SEMI-CONS, UNCEMENTED, METAL/POLY, POROUS

Model Number 71334946

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2020

Event Type  malfunction  

Event Description

It was reported that during a thr surgery, when implanting the 46/28 liner, the liner is smaller than the out cup.Finally another of the same size liner was used to complete the surgery.Delay reported was less or equal than 30 minutes.

Manufacturer Narrative

It was reported that during a thr surgery, when implanting the 46/28 liner, the liner is smaller than the out cup.Finally another same size liner was used to complete the surgery.Delay reported was less or equal to 30 minutes.The affected liner, intended for use in treatment, was returned and evaluated.A visual inspection of the device shows damage on the surface of the device, probably due to attempted implantation.Our quality team completed dimensional analysis on the returned product for all critical-to-quality features.Some features were noted oversized which relate to mating features on the exterior of the part.The surface of the diameter is visually damaged around the part due to the attempted implantation.No other deviations were noted.Plastic is easily distorted during attempted implantation, especially when attempting to mate with a rigid surface like the titanium on reflection shells.These surface finish changes (dings, scratches, scuffs, rubs) are sufficient to alter the measured reading during evaluation.For this reason, a dimensional analysis of this part is inconclusive at this time.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.There is no information that would suggest the device failed to meet specifications.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.Based on this investigation, the need for corrective action is not indicated.Some potential causes of the reported event could include but are not limited to surgical technique used or user/procedural variance.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.Case-2020-00015991-1.

• Brand Name: R3 20 DEG XLPE ACET LNR 28MM X 46MM
• Type of Device: PROSTHE, HIP, SEMI-CONS, UNCEMENTED, METAL/POLY, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10557388
• MDR Text Key: 207702468
• Report Number: 1020279-2020-04691
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598097
• UDI-Public: 03596010598097
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71334946
• Device Catalogue Number: 71334946
• Device Lot Number: 19GM06486
• Date Manufacturer Received: 02/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1