MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY AFIT HO POR PL HA SZ 11; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 71935583

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(6).

Event Description

It was reported that, during a thr surgery, when an anthology afit ho por pl ha sz 11 was going to be implanted, the stem sat up 5 mm from where the broach sat.The stem was explanted, surgeon rebroached and tried to seat the 11ho stem but it kept sitting up.So it was believed it was actually a bigger stem than a size 11.Surgeon went up to a 12 broach.Another 11ho stem was opened and the same issue occurred.This stem was implanted even though it was sitting up proximally.The procedure was completed, after a significant delay.No other complications were reported.

• Brand Name: ANTHOLOGY AFIT HO POR PL HA SZ 11
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 18852401
• MDR Text Key: 337145901
• Report Number: 1020279-2024-00505
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00885556686546
• UDI-Public: 885556686546
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 71935583
• Device Lot Number: 20BM03480
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1