MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71332754

Device Problem Scratched Material (3020)

Patient Problem Injury (2348)

Event Date 04/08/2020

Event Type  Injury  

Event Description

It was reported that during surgery, liner (71332754) was implanted and when trial head (75100856) was done being used to make surgical assessment of length and offset, scratches were noticed on liner.Since no backup device was available, a liner with different size was used to complete the procedure (71339554).Once the stem and head (71343200) were implanted, as surgeon was trying to remove the head, stem and head were removed as one piece and scratches were noticed on the oxinium head.Procedure was completed with a backup device of the same size for the head.A delay of less than 1 hour was reported.

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 54MM
• 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: 10022546
• MDR Text Key: 189874271
• Report Number: 1020279-2020-01443
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010597991
• UDI-Public: 03596010597991
• 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,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71332754
• Device Catalogue Number: 71332754
• Device Lot Number: 17AM07187
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention