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
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/08/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10022546
• Report Number: 1020279-2020-01443
• Device Sequence Number: 14156297
• Product Code: MBL
• UDI-Device Identifier: 03596010597991
• UDI-Public: 03596010597991
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71332754
• Device Catalogue Number: 71332754
• Device Lot Number: 17AM07187
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 04/08/2020; 08/25/2021
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 06/21/2020; 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention