MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY AFIT SO POR PL HA SZ 7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71935567
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tha surgery, the implant size 7 standard offset anthology stem sat 5 mm from where the level of the broach was.The surgeon had to extract and re-broach seven times.He attempted to broach larger with the size 8 broach, but was concerned if he advanced it any further he would split the femur.Ultimately he could not sink the size 7 implant to the level he needed so he inserted a size 6 with a longer neck length.It is unknown if there was a delay.The patient was not harmed beyond the described event.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports the size 7 stem sat 5 mm proud.Per email communication, the surgeon re-broached seven times, and attempted to broach larger with the size 8 broach but was concerned the femur would split.Ultimately, a size 6 stem with a longer neck.Was implanted.To date, the requested surgical report and x-rays have not been provided.There was no patient injury reported, and it is unknown whether there was a significant surgical delay.No further medical assessment is warranted at this time.Should clinically relevant documentation or information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to sizing issue, user error, surgical technique or procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.

• Brand Name: ANTHOLOGY AFIT SO POR PL HA SZ 7
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10796090
• Report Number: 1020279-2020-06255
• Device Sequence Number: 17058108
• Product Code: LPH
• UDI-Device Identifier: 00885556686386
• UDI-Public: 885556686386
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K172684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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 Catalogue Number: 71935567
• Device Lot Number: 19JM19645
• Initial Date Received by Manufacturer: 10/17/2020
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 08/20/2021
• 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