MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF INTERFIT THRD HOLE COVER PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71330001

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  Injury  

Event Description

It was reported that, during hip replacement, two (2) reflection interfit threaded hole covers failed to be screwed into the implanted r-3 acetabular cup 52-mm. Surgery was resumed, after a non-significant delay, with a change in surgical technique. This change was made in a way in which the cup hole was left unscrewed and a r-3 xlpe r3 xlpe acetabular liner 52/36-mm was inserted directly. Patient was not harmed as consequence of this problem.

• Brand Name: REF INTERFIT THRD HOLE COVER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12129374
• MDR Text Key: 260295370
• Report Number: 1020279-2021-05776
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K960094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71330001
• Device Catalogue Number: 71330001
• Device Lot Number: 21DM18086
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/07/2021 Patient Sequence Number: 1