MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335752

Device Problem Fitting Problem (2183)

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

Event Date 04/23/2018

Event Type  malfunction  

Event Description

R3 implant 52 linear was not fitting in the cup 36mmid, 52 mmod.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection of the returned liner indicated damage to the outer and inner articulating surface, lip, and locking bead root.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.The features that could be measured were within specification.A review of complaint history on the listed part revealed no additional complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull hu3 2bn; UK
• MDR Report Key: 7509839
• MDR Text Key: 108082326
• Report Number: 1020279-2018-00920
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598332
• UDI-Public: 03596010598332
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 71335752
• Device Lot Number: 17EMI3735
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1