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
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(6).
Event or Problem 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.
Additional Manufacturer Narrative
G3: report source section h3, h6: the associated device was returned and evaluated.The visual inspection revealed that no damage was able to be detected by naked eye.A dimensional evaluation performed on the device revealed that the part was found to be within the overlay with no issues.Part was confirmed to be the correct size and passed dimensional inspection for external features on overlay and caliper inspection.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.No defects were found on the returned device, therefore no factors that can contribute to the reported event can be delineated.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTHOLOGY AFIT HO POR PL HA SZ 11
• Common Device Name: 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
• Report Number: 1020279-2024-00505
• Device Sequence Number: 18006773
• Product Code: LPH
• UDI-Device Identifier: 00885556686546
• UDI-Public: 885556686546
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K172684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown