MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POROUS SZ 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71356106
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right hip revision surgery was performed due to septic tha status and infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, the root cause of the reported revision for abductor tear and heterotopic ossification cannot be concluded.The revision for elevated cocr levels and acetabular loosening are consistent with findings associated with metal debris.However, without the supporting lab/pathology results, radiographs, and/or the analysis of the explanted components, the root cause of the reported symptoms noted in the legal claim cannot be confirmed, and it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.No conclusion can be made regarding the patient¿s vision.The patient impact beyond the revision and post-operative healing cannot be determined.No further clinical assessment is warranted at this time.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation, the reported event could not be confirmed.The clinical/medical team concluded, the root cause of the reported revision for abductor tear and heterotopic ossification cannot be concluded.The revision for elevated cocr levels and acetabular loosening are consistent with findings associated with metal debris.However, without the supporting lab/pathology results, radiographs, and/or the analysis of the explanted components, the root cause of the reported symptoms noted in the legal claim cannot be confirmed, and it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.No conclusion can be made regarding the patient¿s vision.The patient impact beyond the revision and post-operative healing cannot be determined.No further clinical assessment is warranted at this time.Infection is a potential complication associated with any surgery.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Some potential probable causes could include contamination, patient reaction or a post-operative healing issue.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual device involved our investigation cannot proceed.

• Brand Name: ANTHOLOGY HO POROUS SZ 6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 8628224
• Report Number: 1020279-2019-02001
• Device Sequence Number: 2169021
• Product Code: JDI
• UDI-Device Identifier: 03596010567888
• UDI-Public: 03596010567888
• Combination Product (Y/N): N
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/10/2023

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 Expiration Date: 04/27/2017
• Device Model Number: 71356106
• Device Catalogue Number: 71356106
• Device Lot Number: 07DM15621A
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019; 05/03/2020; 05/25/2022; 10/09/2023
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 10/24/2019; 05/13/2020; 06/01/2022; 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown