MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71357104
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a thr surgery was performed on (b)(6) 2022, the patient experienced inflammation, and chose suppression antibiotics over revision.The patient went off antibiotics and inflamed again.This adverse event was treated by a revision surgery on (b)(6) 2023, in which a anthology ho por pl ha sz 4 was explanted.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, devices analysis could not be performed.The clinical/medical investigation concluded that, although it was reported the patient had a revision due to infection, as of the date of this medical investigation, supporting clinical documentation has not been provided.Therefore, a clinical root cause of the reported infection cannot be confirmed with the limited information provided.The patient impact beyond the reported infection and subsequent revision cannot be determined.No further clinical/medical assessment is warranted at this time.A review of the production order for stem, head and liner did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The provided product identification information for shell did not match any known release of this part and thus a manufacturing record review could not be conducted.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data did not reveal similar events for the listed devices.A review of the instructions for use documents for total hip systems revealed that the patient should be advised to report any pain, decrease in range of motion, swelling, fever, squeaking, clicking, popping, grating, or grinding noises, and unusual incidences.Besides, prophylactic antibiotics should be recommended to the patient, similar to those suggested by the american heart association, this has been identified as postoperative warnings and precautions.A review of the risk management files 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 these products and event.A review of the sterilization records of of stem, head and liner revealed the batches were sterilized within normal parameters.Unable to perform task for shell, the reported part number and batch number did not match in the system with any known release for this part number, therefore a review of the sterilization records could not be conducted with the information provided.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.We consider this investigation closed.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 16547169
• Report Number: 1020279-2023-00540
• Device Sequence Number: 14954427
• Product Code: JDI
• UDI-Device Identifier: 03596010559593
• UDI-Public: 03596010559593
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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 Model Number: 71357104
• Device Catalogue Number: 71357104
• Device Lot Number: 2OHM19136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/05/2023
• 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: Required Intervention
• Patient Sex: Unknown